FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
MDR report key: 2945882
·
Received February 6, 2013
Report
- Report Number
- 3015876-2013-00090
- Event Type
- Malfunction
- Date Received
- February 6, 2013
- Date of Event
- January 8, 2013
- Report Date
- January 8, 2013
- Manufacturer
- PHYSIO-CONTROL, INC
- Product Code
- LDD
- PMA / PMN Number
- K063119
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PHYSIO-CONTROL EXAMINED THE CUSTOMER'S DEVICE BUT WAS UNABLE TO VERIFY THE REPORTED INTERMITTENT LOCK-UP FAILURE. PHYSIO DID OBSERVE THAT THE SCREEN WAS WHITE, BUT STATED THAT THE WHITE SCREEN DID NOT INTERFERE WITH ENERGY DELIVERY DURING TESTING. PHYSIO THEN REPLACED BOTH THE SYSTEM CONTROLLER AND USER INTERFACE PCB ASSEMBLIES AND AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE.
Description of Event or Problem · 1
THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD INTERMITTENTLY LOCK-UP WITH A WHITE SCREEN UPON POWERING THE DEVICE ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 50854 | LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR | DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) | LDD | PHYSIO-CONTROL, INC | 20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |