FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK CR PLUS DEFIBRILLATOR
MDR report key: 2152887
·
Received June 28, 2011
Report
- Report Number
- 3015876-2011-00498
- Event Type
- Malfunction
- Date Received
- June 28, 2011
- Date of Event
- May 31, 2011
- Report Date
- May 31, 2011
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K011144
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED THE CAUSE OF THE REPORTED FAILURE TO BE A CRACKED CAPACITOR, DESIGNATOR C177 FROM THE ANALOG PCB ASSEMBLY. THE CUSTOMER RECEIVED A REPLACEMENT DEVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE HAD ALL THREE ICONS ILLUMINATED (SERVICE, ATTENTION AND CHARGE-PAK). THIS FAILURE IS INDICATIVE OF THE DEVICE NOT HAVING ENOUGH POWER TO REMAIN ON LONG ENOUGH TO DELIVER APPROPRIATE DEFIBRILLATION THERAPY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.
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 |