FDA Adverse Event
Death
Summary report: N
UNI-VENT, MODEL 731
MDR report key: 11703667
·
Received April 21, 2021
Report
- Report Number
- 1220908-2021-01356
- Event Type
- Death
- Date Received
- April 21, 2021
- Date of Event
- April 12, 2021
- Report Date
- April 13, 2021
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- CBK
- PMA / PMN Number
- K111473
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RO
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE CUSTOMER WAS CONTACTED FOR RETURN OF THE SUSPECT PRODUCT. THE PRODUCT HAS NOT BEEN RETURNED TO ZOLL FOR EVALUATION.
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED AN "O2 SUPPLY PRESSURE HIGH FAILURE-1041" ERROR MESSAGE. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED. PLEASE REFERENCE MEDWATCH REPORTS 1220908-2021-01355 AND 1220908-2021-01357 FOR SIMILAR EVENTS REPORTED FROM THE SAME CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 601331 | UNI-VENT, MODEL 731 | VENTILATOR | CBK | ZOLL MEDICAL CORPORATION | 799-EGB2-00-12 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |