FDA Adverse Event
Malfunction
Summary report: N
R SERIES DEFIBRILLATOR
MDR report key: 9708348
·
Received February 13, 2020
Report
- Report Number
- 1220908-2020-00278
- Event Type
- Malfunction
- Date Received
- February 13, 2020
- Report Date
- January 23, 2020
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- UDI-DI
- 00847946017392
- PMA / PMN Number
- K060559/P160
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS COMPLETED.
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION AND THE CUSTOMER'S REPORT WAS NOT REPLICATED OR CONFIRMED. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING INCLUDING SIGNAL DETECTION AND ENERGY TESTING WITHOUT DUPLICATING THE REPORT. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 171429 | R SERIES DEFIBRILLATOR | DEFIBRILLATOR/PACEMAKER | MKJ | ZOLL MEDICAL CORPORATION | R SERIES | NA | 00847946017392 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |