FDA Adverse Event
Malfunction
Summary report: N
R SERIES
MDR report key: 20821631
·
Received December 2, 2024
Report
- Report Number
- 1220908-2024-04262
- Event Type
- Malfunction
- Date Received
- December 2, 2024
- Report Date
- November 11, 2024
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- UDI-DI
- 00847946017163
- PMA / PMN Number
- P160022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. THE CUSTOMER'S REPORT WAS DUPLICATED AND ATTRIBUTED TO A FAULTY ONESTEP/MFE CABLE. THE ONESTEP/MFE CABLE WAS REPLACED TO RESOLVE THE REPORT. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS OF 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 FAILED TO DISCHARGE USING EXTERNAL PADDLES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 334051 | R SERIES | DEFIBRILLATOR/PACEMAKER | MKJ | ZOLL MEDICAL CORPORATION | 30001000001110012 | NA | 00847946017163 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |