FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK CR PLUS DEFIBRILLATOR
MDR report key: 2110370
·
Received April 25, 2011
Report
- Report Number
- 3015876-2011-00347
- Event Type
- Malfunction
- Date Received
- April 25, 2011
- Date of Event
- March 28, 2011
- Report Date
- March 28, 2011
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K011144
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PHYSIO-CONTROL IS AWAITING THE ARRIVAL OF THE DEVICE AND CONTINUES TO INVESTIGATION THE REPORTED FAILURE. PHYSIO WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.
Description of Event or Problem · 1
IT WAS REPORTED BY THE CUSTOMER THAT THE DEVICE WAS DISPLAYING ALL THREE ICONS (SERVICE, ATTENTION AND CHARGE-PAK) PRIOR TO REPLACING THE CHARGE-PAK ASSEMBLY. THIS FAILURE IS INDICATIVE OF A DEVICE THAT WILL NOT REMAIN POWERED ON LONG ENOUGH FOR APPROPRIATE DEFIBRILLATION DELIVERY. THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT WITH THE REPORTED FAILURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK CR PLUS DEFIBRILLATOR | MKJ | PHYSIO-CONTROL, INC. | CR PLUS | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |