FDA Adverse Event
Malfunction
Summary report: N
UNI-VENT MODEL 731
MDR report key: 6169006
·
Received December 13, 2016
Report
- Report Number
- 1220908-2016-03106
- Event Type
- Malfunction
- Date Received
- December 13, 2016
- Report Date
- November 27, 2016
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- CBK
- PMA / PMN Number
- K111473
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
Additional Manufacturer Narrative · 1
THE COMPLAINANT WAS CONTACTED FOR RETURN OF THE DEVICE. THE DEVICE HAS NOT BEEN RETURNED TO ZOLL FOR EVALUATION.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED AN "OFF SET SELF CHECK FAILURE-1174" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 821005 | UNI-VENT MODEL 731 | VENTILATOR | CBK | ZOLL MEDICAL CORPORATION | 799-AEV1-01 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |