FDA Adverse Event
Malfunction
Summary report: N
HEART START XL
MDR report key: 2822086
·
Received October 9, 2012
Report
- Report Number
- 1218950-2012-03380
- Event Type
- Malfunction
- Date Received
- October 9, 2012
- Report Date
- September 14, 2012
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K001725
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THE UNIT DOES NOT WORK ON AC POWER. NO PT INVOLVEMENT WAS REPORTED. A PHILIPS FSE EVALUATED THE DEVICE AND VERIFIED THE FAILURE. THE ISSUE WAS DIAGNOSED AS AN AC POWER SUPPLY FAILURE. THE AC POWER SUPPLY WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE REMAINS AT THE CUSTOMER SITE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE UNIT DOES NOT WORK ON AC POWER. NO PT INVOLVEMENT WAS REPORTED.
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 |