FISHER & PAYKEL HEALTHCARE LTD

FDA MAUDE device safety record · 1999–2026

What the Data Shows About FISHER & PAYKEL HEALTHCARE LTD

FISHER & PAYKEL HEALTHCARE LTD is associated with 14,015 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 1999 through 2026. Of the total, 70 are coded as death reports and 173 as injury reports, with the remainder classified as malfunctions or other event types. These counts reflect reports submitted to the FDA by manufacturers, healthcare facilities, and patients — they are raw signal, not adjudicated safety findings, and higher-volume manufacturers or older product portfolios naturally generate larger raw counts.

The reports span 19 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for FISHER & PAYKEL HEALTHCARE LTD should be reviewed at the device-family level rather than company-wide. Across those devices, 5 distinct event types appear in the record, led by Malfunction at 13,762 reports (98.2% of total). Patient-outcome categorizations are reported across 14 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 24 years of MAUDE data, with the peak single-year volume reaching 2,163 reports — trend shape can reflect shifts in device sales, FDA reporting requirements, or post-market recall activity as much as intrinsic device performance. The MAUDE system is one input among many in FDA post-market surveillance and does not draw safety conclusions from individual submissions. All figures reflect the openFDA snapshot refreshed on , and nothing on this page is medical or regulatory advice — consult a qualified clinician or the FDA for current safety communications.

14,015
Total Reports
70
Death Reports
173
Injury Reports
19
Device Types

Event Types

Malfunction 13,762 (98.2%)
Injury 173 (1.2%)
Death 70 (0.5%)
5 (0.0%)
Other 5 (0.0%)

Patient Outcomes

13,674 (97.6%)
Required Intervention 106 (0.8%)
Death 71 (0.5%)
Other 68 (0.5%)
Hospitalization 25 (0.2%)
Life Threatening 21 (0.1%)
R 11 (0.1%)
L 9 (0.1%)
O 8 (0.1%)
Disability 6 (0.0%)
H 5 (0.0%)
Congenital Anomaly 4 (0.0%)
D 2 (0.0%)
S 1 (0.0%)

Yearly Trend

99
1999: 2
00
2000: 3
01
2001: 11
02
2002: 1
07
2007: 16
08
2008: 16
09
2009: 73
10
2010: 257
11
2011: 467
12
2012: 704
13
2013: 688
14
2014: 638
15
2015: 463
16
2016: 816
17
2017: 979
18
2018: 930
19
2019: 1,108
20
2020: 283
21
2021: 444
22
2022: 1,125
23
2023: 1,142
24
2024: 947
25
2025: 2,163
26
2026: 739

Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a manufacturer's products are unsafe — higher-volume manufacturers naturally generate more reports.