FDA Adverse Event
Malfunction
Summary report: N
UNI-VENT, MODEL 731
MDR report key: 14044714
·
Received April 7, 2022
Report
- Report Number
- 1220908-2022-01142
- Event Type
- Malfunction
- Date Received
- April 7, 2022
- Report Date
- March 17, 2022
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- CBK
- UDI-DI
- 00847946020620
- PMA / PMN Number
- K111473
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
Additional Manufacturer Narrative · 0
THE DEVICE WAS RETURNED TO ZOLL MEDICAL SINGAPORE. THE CUSTOMER'S REPORT WAS VERIFIED AND ATTRIBUTED TO THE SMART PNEUMATIC MODULE BOARD. THE SMART PNEUMATIC MODULE BOARD WILL BE REPLACED ONCE THE PO IS APPROVED. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.
Description of Event or Problem · 0
COMPLAINTANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED A "RUNTIME CALIBRATION FAILURE - 1051" ERROR MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2144684 | UNI-VENT, MODEL 731 | VENTILATOR | CBK | ZOLL MEDICAL CORPORATION | 799-EMVP-04 | NA | 00847946020620 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |