FDA Adverse Event
Malfunction
Summary report: N
HEART START XL
MDR report key: 2941759
·
Received December 27, 2012
Report
- Report Number
- 1218950-2012-04261
- Event Type
- Malfunction
- Date Received
- December 27, 2012
- Report Date
- December 4, 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 STATES THE MAIN BOARD IS BROKEN AND THE DEVICE CANNOT BOOT UP WITH POWER SUPPLY. NO PT INVOLVEMENT WAS REPORTED. THIS COMPLAINT IS STILL BEING INVESTIGATED. A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
THE CUSTOMER STATES THE MAIN BOARD IS BROKEN AND THE DEVICE CANNOT BOOT UP WITH POWER SUPPLY. 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 |