FDA Adverse Event
Malfunction
Summary report: N
UNI-VENT, MODEL 731
MDR report key: 15932462
·
Received December 7, 2022
Report
- Report Number
- 1220908-2022-04761
- Event Type
- Malfunction
- Date Received
- December 7, 2022
- Report Date
- November 16, 2022
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- CBK
- UDI-DI
- 00847946024208
- PMA / PMN Number
- K111473
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS COMPLETED.
Additional Manufacturer Narrative · 0
THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION; THE CUSTOMER'S REPORT WAS DUPLICATED AND ATTRIBUTED TO A FAULTY INTEGRATED CIRCUIT ON THE CENTRAL PROCESSING UNIT. THE CENTRAL PROCESSING UNIT WAS REPLACED TO RESOLVE THE REPORT. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.
Description of Event or Problem · 0
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE WOULD NOT POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2470490 | UNI-VENT, MODEL 731 | VENTILATOR | CBK | ZOLL MEDICAL CORPORATION | 799-EGB2-00-01 | NA | 00847946024208 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |