FDA Adverse Event
Death
Summary report: N
BREEZE
MDR report key: 417635
·
Received September 20, 2002
Report
- Report Number
- 2431480-2002-00001
- Event Type
- Death
- Date Received
- September 20, 2002
- Report Date
- September 20, 2002
- Manufacturer
- HUNTLEIGH HEALTHCARE PLC
- Product Code
- FNM
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
COMPANY WAS NOTIFIED TO REMOVE ALL BREEZE LOW AIR LOSS SYSTEMS FROM NURSING HOME DUE TO AN APPARENT PT DEATH WHILE ON THE SYSTEM. NO INFO HAS BEEN FORTHCOMING FROM FACILITY DESPITE EFFORTS BY COMPANY. PHONE CALL TO COMPANY FROM STATE DEPT OF HEALTH AND HUMAN SERVICES IS LEADING CO TO BELIEVE THAT IT MAY BE AN ENTRAPMENT FATALITY, BUT NO CONCLUSIVE INFO/DETAILS HAVE BEEN RECEIVED BY COMPANY. THE SYSTEM HAS NOT BEEN RETURNED TO THE COMPANY FOR INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BREEZE | LOW AIR LOSS MATTRESS REPLACEMENT | FNM | HUNTLEIGH HEALTHCARE PLC | MDC-BREEZE | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Death |