FDA Adverse Event
Malfunction
Summary report: N
INTERNAL PADDLES OPTION FOR DEFIBRILLATOR/MONITOR
MDR report key: 1882443
·
Received October 20, 2010
Report
- Report Number
- 1218950-2010-01979
- Event Type
- Malfunction
- Date Received
- October 20, 2010
- Report Date
- September 21, 2010
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4), THE CUSTOMER REPORTED THAT THE INTERNAL PADDLES FAILED THE OHMS TEST AND WERE NOT DETECTED WHEN ATTACHED TO DEFIBRILLATOR. THE INTERNAL PADDLES WERE REPLACED TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE INTERNAL PADDLES FAILED THE OHMS TEST AND WERE NOT DETECTED WHEN ATTACHED TO DEFIBRILLATOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERNAL PADDLES OPTION FOR DEFIBRILLATOR/MONITOR | MKJ | PHILIPS HEALTHCARE | M4742A | DATE CODE 1/10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |