FDA Adverse Event
Malfunction
Summary report: N
R SERIES DEFIBRILLATOR
MDR report key: 6536550
·
Received May 2, 2017
Report
- Report Number
- 1220908-2017-00989
- Event Type
- Malfunction
- Date Received
- May 2, 2017
- Report Date
- April 14, 2017
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- DRT
- UDI-DI
- 00847946016173
- PMA / PMN Number
- K060559
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MALFUNCTION WAS OBSERVED DURING INCOMING TESTING; HOWEVER AFTER DISASSEMBLING THE DEVICE TO DETERMINE ROOT CAUSE, THE MALFUNCTION WAS NO LONGER SEEN. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING WITHOUT DUPLICATING THE MALFUNCTION. THE ANALOG BOARD WAS REPLACED AS A PRECAUTION. THE DEVICE PASSED THE FINAL TEST PROCEDURE, WAS RECERTIFIED, AND RETURNED TO THE CUSTOMER. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED AN "ECG DISABLED" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 318681 | R SERIES DEFIBRILLATOR | DEFIBRILLATOR/PACEMAKER | DRT | ZOLL MEDICAL CORPORATION | R SERIES | NA | 00847946016173 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |