FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK CR PLUS DEFIBRILLATOR
MDR report key: 2182102
·
Received June 23, 2011
Report
- Report Number
- 3015876-2011-00490
- Event Type
- Malfunction
- Date Received
- June 23, 2011
- Date of Event
- April 4, 2011
- Report Date
- May 27, 2011
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K011144
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PHYSIO-CONTROL ISOLATED THE CAUSE OF THE MALFUNCTION TO BE THE ANALOG PCB ASSEMBLY. THE R170 RESISTOR WAS BURNED AND THE U22 CHIP NON-FUNCTIONAL. HOWEVER, FURTHER COMPONENT CAUSE OF THE FAILURE FROM THE PCB WAS NOT DETERMINED. A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER.
Description of Event or Problem · 1
DURING A NORMAL TESTING/INSPECTION, IT WAS REPORTED THAT THE DEVICE ILLUMINATED THE SERVICE WRENCH. PHYSIO-CONTROL EVALUATED THE DEVICE AND FOUND THAT IT WAS UNABLE TO PROVIDE DEFIBRILLATION THERAPY; IT FAILED TO ANALYZE AN ECG RHYTHM, CHARGE AND DELIVER ENERGY. THERE WAS NO PT USE ASSOCIATED WITH THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK CR PLUS DEFIBRILLATOR | MKJ | PHYSIO-CONTROL, INC. | CRPLUS | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |