2020 data FDA MAUDE openFDA FDA Class II

Refrigerator, Freezer, Blood Storage

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §864.9700 (Hematology panel).

FDA MAUDE casebook

openFDA event book Refrigerator, Freezer, Blood Storage LIGHT-BOOK · MAUDE

#985 of 1000 · 383 reports · 1992–2020

  • BOOK 383 reports
  • RANK #985 of 1000
  • DEATH 3 death-typed
  • INJ 28 injury-typed
  • MALF 326 malfunction
  • SPAN 1992–2020
  • PEAK 2006: 127
  • PHOTO Scissors, Ophthalmic

Nearest event-volume peer: Scissors, Ophthalmic (2 report gap)

Refrigerator, Freezer, Blood Storage sits #985 of 1000 among tracked device types with 383 MAUDE reports spanning 1992–2020. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Injury-coded reports sit below the device-type norm

Refrigerator, Freezer, Blood Storage carries 7.3% INJURY-coded reports, 23.0pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.8% corpus 1.5% · below corpus mean (-0.7 pp)
  • INJ 7.3% corpus 30.3% · below corpus mean (-23.0 pp)
  • MALF 85.1% corpus 64.8% · above corpus mean (+20.3 pp)

Lead product-problem code Break is 43% of coded problems · Lead manufacturer BAXTER HEALTHCARE CORP. accounts for 47% of manufacturer-tagged reports · Top event location is 95% of location-tagged rows .

Refrigerator, Freezer, Blood Storage in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Refrigerator, Freezer, Blood Storage carries 383 MAUDE reports, ranked #985 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 326 (85.1%)
Injury 28 (7.3%)
18 (4.7%)
Other 8 (2.1%)
Death 3 (0.8%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

322 (82.8%)
Required Intervention 25 (6.4%)
Other 19 (4.9%)
Hospitalization 13 (3.3%)
R 5 (1.3%)
Death 3 (0.8%)
L 1 (0.3%)
Life Threatening 1 (0.3%)

Top Product Problems

Break 213
Crack 93
Use of Device Problem 24
Leak/Splash 23
Material Rupture 16
Replace 14
Burst Container or Vessel 13
Tears, rips, holes in device, device material 13
Component(s), broken 12
Fluid/Blood Leak 11
Unknown (for use when the device problem is not known) 11
Split 10
Contamination 6
Insufficient Flow or Under Infusion 6
Other (for use when an appropriate device code cannot be identified) 6
Port leak(s) 5
Disconnection 4
Material Separation 4
Microbial Contamination of Device 4
Component Missing 3

Yearly Trend

92
1992: 2
99
1999: 1
00
2000: 1
01
2001: 1
02
2002: 5
03
2003: 78
04
2004: 64
05
2005: 61
06
2006: 127
07
2007: 1
08
2008: 32
09
2009: 1
10
2010: 2
12
2012: 1
13
2013: 1
19
2019: 3
20
2020: 2

Reports rose to 3 in 2019, up from an average of 1 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Refrigerator, Freezer, Blood Storage

Event Locations

365 (95.3%)
HOSPITAL 8 (2.1%)
NO INFORMATION 3 (0.8%)
I 2 (0.5%)
INVALID DATA 1 (0.3%)
LABORATORY/PATHOLOGY DEPARTMENT 1 (0.3%)
NOT APPLICABLE 1 (0.3%)
OTHER 1 (0.3%)
UNKNOWN 1 (0.3%)

Compare BAXTER HEALTHCARE CORP. vs BAXTER HEALTHCARE →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Refrigerator, Freezer, Blood Storage: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (383 here).

Similar death-typed counts

Nearest other device types by death-typed report count (3 here), distinct from the volume row.

Disclaimer: MAUDE figures for Refrigerator, Freezer, Blood Storage are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Refrigerator, Freezer, Blood Storage; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.