FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK CR PLUS DEFIBRILLATOR
MDR report key: 1981230
·
Received February 1, 2011
Report
- Report Number
- 3015876-2011-00091
- Event Type
- Malfunction
- Date Received
- February 1, 2011
- Date of Event
- November 23, 2010
- Report Date
- November 23, 2010
- Manufacturer
- PHYSIO-CONTROL, INC
- Product Code
- MKJ
- PMA / PMN Number
- K011144
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PHYSIO- CONTROL DETERMINED THE CAUSE OF THE MALFUNCTION TO BE U35 IC CHIP FROM THE ANALOG PCB ASSEMBLY. A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE ILLUMINATED THE WRENCH ICON AND LOGGED EVENT CODES IN THE MEMORY. THERE WAS NO PT USE ASSOCIATED WITH THE EVENT. PHYSIO- CONTROL'S DEVICE INVESTIGATION FOUND A CRITICAL MALFUNCTION, THE DEVICE WAS NOT ABLE TO DETECT A THERAPY CABLE CONNECTION TO DELIVER DEFIBRILLATION.
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 |