FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 15 MONITOR/DEFIBRILLATOR
MDR report key: 1964223
·
Received December 22, 2010
Report
- Report Number
- 3015876-2010-01403
- Event Type
- Malfunction
- Date Received
- December 22, 2010
- Date of Event
- December 2, 2010
- Report Date
- December 2, 2010
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K082937
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE PROBLEM AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.
Description of Event or Problem · 1
PHYSIO-CONTROL IS CURRENTLY INVESTIGATING FIELD FAILURES OF THE SINGLE BOARD COMPUTER (SBC) ON THE SYSTEM PCB ASSEMBLY DUE TO PRESENCE OF FLUX RESIDUE AROUND THE U10 IC CHIP. THE OBSERVED ISSUE HAS BEEN ATTRIBUTED TO DEVICE FAILURE TO BOOT OR UNIT RESETS FAILURE MODES. THERE HAS BEEN NO ADVERSE EVENTS ASSOCIATED WITH THE FAILURES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK 15 MONITOR/DEFIBRILLATOR | MKJ | PHYSIO-CONTROL, INC. | 15 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |