FDA Adverse Event
Injury
Summary report: N
LIFEPAK 12
MDR report key: 21653100
·
Received March 20, 2025
Report
- Report Number
- MW5167851
- Event Type
- Injury
- Date Received
- March 20, 2025
- Date of Event
- December 27, 2021
- Report Date
- January 31, 2025
- Manufacturer
- PHYSIO-CONTROL MAASTRICHT, INC. / STRYKER CORP.
- Product Code
- MKJ
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MN, US
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
ON (B)(6) 2021, THE CHILD UNDERWENT CORRECTION OF ABNORMAL ORIGIN OF CORONARY ARTERY. THE NURSE REPORTED THAT WHEN THE DEFIBRILLATOR WAS USED TO DEFIBRILLATE THE CHILD DURING THE OPERATION, THE ENERGY WAS WEAK. AFTER URGENTLY REPLACING IT WITH ANOTHER DEFIBRILLATOR, IT RETURNED TO NORMAL. DISABLED THE FAULTY DEFIBRILLATOR AND TOOK IT AWAY FOR TESTING. THIS EVENT INCREASED SURGICAL RISK. DISCLAIMER STATEMENT: THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 543497 | LIFEPAK 12 | AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | MKJ | PHYSIO-CONTROL MAASTRICHT, INC. / STRYKER CORP. | LIFEPAK 12 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |