FDA Adverse Event
Malfunction
Summary report: N
R SERIES
MDR report key: 20863515
·
Received December 6, 2024
Report
- Report Number
- 1220908-2024-04324
- Event Type
- Malfunction
- Date Received
- December 6, 2024
- Report Date
- November 15, 2024
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- UDI-DI
- 00847946017446
- PMA / PMN Number
- P160022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE WAS EVALUATED BYZ OLL MEDICAL CORPORATION. THE CUSTOMER'S REPORT WAS DUPLICATED AND ATTRIBUTED TO AN INTEGRATED CIRCUIT ON THE DIGITAL BOARD. THE DIGITAL BOARD WAS REPLACED TO RESOLVE THE REPORT. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.
Additional Manufacturer Narrative · 0
ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS COMPLETED.
Description of Event or Problem · 0
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE'S SCREEN TURNED COMPLETELY WHITE AND WAS ILLEGIBLE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2121419 | R SERIES | DEFIBRILLATOR/PACEMAKER | MKJ | ZOLL MEDICAL CORPORATION | 30001004101110013 | NA | 00847946017446 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |