FDA Adverse Event
Malfunction
Summary report: N
AED PRO
MDR report key: 18551866
·
Received January 22, 2024
Report
- Report Number
- 1220908-2024-00142
- Event Type
- Malfunction
- Date Received
- January 22, 2024
- Report Date
- January 2, 2024
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- UDI-DI
- 00847946016128
- PMA / PMN Number
- P160022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION. INTERNAL INSPECTION WAS PERFORMED AND FOUND SCREWS MISSING ON FLEX CIRCUIT ASSEMBLY. SCREWS WERE INSTALLED ON FLEX CIRCUIT ASSEMBLY TO RESOLVE THE REPORT. THE DEVICE WAS RETURNED TO ZOLL'S INVENTORY AND THE CUSTOMER WAS SENT A REPLACEMENT DEVICE. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.
Additional Manufacturer Narrative · 0
ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
Description of Event or Problem · 0
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE PROMPTED A "UNIT FAILED" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2052655 | AED PRO | DEFIBRILLATOR | MKJ | ZOLL MEDICAL CORPORATION | AED PRO | NA | 00847946016128 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |