FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK CR PLUS DEFIBRILLATOR
MDR report key: 2133310
·
Received May 12, 2011
Report
- Report Number
- 3015876-2011-00387
- Event Type
- Malfunction
- Date Received
- May 12, 2011
- Date of Event
- April 18, 2011
- Report Date
- April 18, 2011
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K011144
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER. PHYSIO-CONTROL IS ANTICIPATING THE DEVICE RETURN FOR EVALUATION AND CONTINUES TO INVESTIGATE THE REPORTED EVENT. PHYSIO-CONTROL WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WOULD NOT POWER ON. THE CUSTOMER REPLACED THE CHARGE PAK (INTERNAL HLC BATTERY CHARGER) BUT THE ISSUE PERSISTED. THERE WAS NO PATIENT 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 |