FDA Adverse Event
Malfunction
Summary report: N
UNI-VENT, MODEL 731
MDR report key: 10450093
·
Received August 25, 2020
Report
- Report Number
- 1220908-2020-02551
- Event Type
- Malfunction
- Date Received
- August 25, 2020
- Report Date
- August 4, 2020
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- CBK
- UDI-DI
- 00847946023430
- PMA / PMN Number
- K111473
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
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 (CPU) CENTRAL PROCESSING UNIT BOARD. THE CENTRAL PROCESSING UNIT BOARD WAS REPLACED TO REMEDY THE REPORT. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE POWERED ON WITHOUT DISPLAY. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 911222 | UNI-VENT, MODEL 731 | VENTILATOR | CBK | ZOLL MEDICAL CORPORATION | 799-EMVP-05-01 | NA | 00847946023430 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |