FDA Adverse Event
Malfunction
Summary report: N
X SERIES
MDR report key: 7556761
·
Received May 31, 2018
Report
- Report Number
- 1220908-2018-01488
- Event Type
- Malfunction
- Date Received
- May 31, 2018
- Report Date
- May 10, 2018
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- DRT
- PMA / PMN Number
- K112432/P160
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE PRODUCT FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO ZOLL MEDICAL (B)(4) SERVICE DEPARTMENT FOR EVALUATION AND THE CUSTOMER'S REPORT WAS NOT DUPLICATED UNDER TESTING. REVIEW OF THE DEVICE ACTIVITY LOG DOES SHOW OCCURRENCES OF THE REPORTED ERROR MESSAGE. THE MULTI-FUNCTION CABLE GASKET WAS REPLACED AS A PRECAUTION. ANALYSIS OF 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 |
|---|---|---|---|---|---|---|---|
| 400643 | X SERIES | DEFIBRILLATOR/PACEMAKER | DRT | ZOLL MEDICAL CORPORATION | X SERIES | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |