X SERIES
Report
- Report Number
- 1220908-2023-04651
- Event Type
- Malfunction
- Date Received
- December 4, 2023
- Report Date
- November 13, 2023
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- PMA / PMN Number
- P160022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE CUSTOMER'S REPORT WAS OBSERVED DURING REVIEW OF THE DEVICE DATA LOGS. HOWEVER, THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING INCLUDING BENCH TESTING AND STRESS TESTING WITHOUT DUPLICATING THE REPORT. AN INTERNAL INSPECTION FOUND A DIRTY BATTERY CONNECTION ASSEMBLY AND OXIDIZED BATTERY LUGS WHICH MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORT. THE BATTERY CATCH, BATTERY LUGS, AND BATTERY CONNECTION ASSEMBLY WERE REPLACED AS A PRECAUTION. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.
ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS COMPLETED.
THIS SUPPLEMENTAL MEDWATCH REPORT UPDATES INFORMATION BASED UPON YOUR REQUEST WHICH DIFFERS FROM THE INITIAL MEDWATCH REPORT FILED. PLEASE REFERENCE SECTIONS D4 MODEL # UPDATED, D4 CATALOG # REMOVED. D4 PRIMARY UDI #: ADDED JUSTIFICATION FOR NO UDI, THIS DEVICE WAS MANUFACTURED BEFORE UDI REQUIREMENTS.
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE INAPPROPRIATELY SHUT DOWN. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1503377 | X SERIES | DEFIBRILLATOR/PACEMAKER | MKJ | ZOLL MEDICAL CORPORATION | 610-2231011-01 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |