FDA Adverse Event
Malfunction
Summary report: N
R SERIES
MDR report key: 20026773
·
Received August 22, 2024
Report
- Report Number
- 1220908-2024-02935
- Event Type
- Malfunction
- Date Received
- August 22, 2024
- Report Date
- July 29, 2024
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- UDI-DI
- 00847946017613
- PMA / PMN Number
- P160022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
ZOLL MEDICAL CORPORATION EVALUATED THE DEVICE AND THE DEVICE PERFORMED TO SPECIFICATION. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. REVIEW OF THE LOG CONFIRMED THE DEVICE WAS CONFIGURED FOR CPR/MWP COMPLETE PADS BUT IS DETECTING ONE-STEP BASE ADULT PADS. THEREFORE, THIS CLAIM IS BEING CLOSED AS INCORRECT SEQUENCE SETTING. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.
Description of Event or Problem · 0
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE FAILED SELF TEST. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2178711 | R SERIES | DEFIBRILLATOR/PACEMAKER | MKJ | ZOLL MEDICAL CORPORATION | 30001007201310012 | NA | 00847946017613 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |