FDA Adverse Event
Malfunction
Summary report: N
PURITAN BENNETT
MDR report key: 1202357
·
Received October 10, 2008
Report
- Report Number
- MW5008662
- Event Type
- Malfunction
- Date Received
- October 10, 2008
- Date of Event
- September 23, 2008
- Report Date
- September 26, 2008
- Manufacturer
- TYCO HEALTHCARE PURITAN BENNETT
- Product Code
- CBK
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
NINETY ONE YEAR OLD FEMALE WITH HISTORY OF COPD, RESPIRATORY FAILURE CORONARY ARTERY DISEASE 5/PTRACH ON PURITAN BENNETT 840 VENT. IN 2008 AT 1600, THE VENT ALARMED AND EXHIBITED "RED ALERT" VENT INOP" SIGNAL. VENT CHANGED OUT WITH NO NEGATIVE PT OUTCOME. PT VS= 114/50, 68,18. PT MAINTAINED ADEQUATE TIDAL VOLUMES. ACCORDING TO PURITAN BENNETT ENGINEER REPORT: SYSTEM ERROR LOG= O2 PSOL STUCK OPEN. CODE TYPE = KB0026, TASK 8 BD, ERROR CODE: OX 8000. 840 VENT REPAIRED. DEVICE HOURS = 392.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PURITAN BENNETT | PB 840 | CBK | TYCO HEALTHCARE PURITAN BENNETT | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 91 YR |