PlainHospital

DATASCOPE CORP. - MAHWAH

Manufacturer adverse-event records for DATASCOPE CORP. - MAHWAH come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.

FDA MAUDE device safety record · 2014–2024 · mid-book · elevated Death-code · injury-light

Injury-mix signature

DATASCOPE CORP. - MAHWAH is lighter on Injury codes

Injury-coded event_type share is 0.6% (injury-light tercile) beside 0.75% Death-coded (elevated). Volume band: mid.

What the Injury-mix reading shows for DATASCOPE CORP. - MAHWAH

The standout signal for DATASCOPE CORP. - MAHWAH is Injury-mix: 0.6% Injury-coded (injury-light) beside 0.75% Death-coded, on a mid-book footprint.

Mid-pack volume still shows a clear device fingerprint; the table below is the actionable layer for DATASCOPE CORP. - MAHWAH. Event_type Death/Injury codes differ from patient-outcome rows - see methodology.

Reports span 1 device type, led in this extract by Malfunction at 15,078 (98.6% of event_type total). Peak single-year volume reaches 4,495 reports across 11 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

15,289
Total Reports
114
Event-type Death
97
Injury Reports
1
Device Types

Event Types

Malfunction 15,078 (98.6%)
Death 114 (0.7%)
Injury 97 (0.6%)

Patient Outcomes

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

15,014 (98.3%)
Death 125 (0.8%)
Other 63 (0.4%)
Required Intervention 41 (0.3%)
Life Threatening 18 (0.1%)
R 6 (0.0%)
D 3 (0.0%)
O 3 (0.0%)

Devices (1)

Device Reports
System, Balloon, Intra-Aortic And Control 15,289

Yearly Trend

14
2014: 3
15
2015: 4
16
2016: 2
17
2017: 1
18
2018: 1
19
2019: 1,719
20
2020: 2,266
21
2021: 3,013
22
2022: 3,516
23
2023: 4,495
24
2024: 269

Read our methodology - how this data is sourced, computed, and verified.