FDA Adverse Event
Malfunction
Summary report: N
HEART START XL
MDR report key: 2910642
·
Received December 4, 2012
Report
- Report Number
- 1218950-2012-03980
- Event Type
- Malfunction
- Date Received
- December 4, 2012
- Report Date
- November 12, 2012
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K001725
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED A BUTTON PROBLEM. THERE WAS NO REPORTED PT INVOLVEMENT. THE DEVICE WAS EVALUATED BY A PHILIPS FIELD SERVICE ENGINEER. THE SYMPTOM WAS CLARIFIED AS A FAILURE TO POWER UP. THE ISSUE WAS LOCALIZED TO A FAILURE OF THE OPTICAL SWITCH ASSEMBLY. THE OPTICAL SWITCH ASSEMBLY WAS REPLACED AND THE DEVICE PASSED ALL TESTING.
Description of Event or Problem · 1
THE CUSTOMER REPORTED A BUTTON PROBLEM. THERE WAS NO REPORTED PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEART START XL | MKJ | PHILIPS MEDICAL SYSTEMS | M4735A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |