FDA Adverse Event
Malfunction
Summary report: N
POWERHEART G5 KIT,SEMI,KOR-INTL ENG
MDR report key: 17513097
·
Received August 11, 2023
Report
- Report Number
- 2112020-2023-00685
- Event Type
- Malfunction
- Date Received
- August 11, 2023
- Report Date
- July 23, 2023
- Manufacturer
- CARDIAC SCIENCE CORPORATION
- Product Code
- MKJ
- UDI-DI
- 00812394023141
- PMA / PMN Number
- P160033
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
Additional Manufacturer Narrative · 0
THIS REPORT WAS INADVERTENTLY SUBMITTED AS A DUPLICATE. THE REPORTED EVENT WAS ORIGINALLY REPORTED UNDER MEDWATCH 2112020-2023-00688.
Description of Event or Problem · 0
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE PROMPTED A "UNIT FAILED" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 564486 | POWERHEART G5 KIT,SEMI,KOR-INTL ENG | AUTOMATED EXTERNAL DEFIBRILATOR | MKJ | CARDIAC SCIENCE CORPORATION | G5S-19A | NA | 00812394023141 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |