FDA Adverse Event
Injury
Summary report: N
HEARTSTREAM XL
MDR report key: 1351655
·
Received March 23, 2009
Report
- Report Number
- 1218950-2009-00311
- Event Type
- Injury
- Date Received
- March 23, 2009
- Report Date
- February 25, 2008
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- MKJ
- PMA / PMN Number
- K001725
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PHILIPS REPRESENTATIVE REPORTED THAT THE UNIT FAILED TO POWER UP DURING THE SHIFT CHECK. THE DEVICE WAS EVALUATED BY A PHILIPS CONTRACTED DISTRIBUTOR, AND AN OPTICAL SWITCH FAILURE WAS IDENTIFIED. THE COMPLAINT IS STILL BEING INVESTIGATED BY PHILIPS TO CONFIRM THE ROOT CAUSE OF THE FAILED COMPONENT. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
THE PHILIPS REPRESENTATIVE REPORTED THAT THE UNIT FAILED TO POWER UP DURING THE SHIFT CHECK. THIS EVENT IS AN OPTICAL SWITCH MALFUNCTION WHICH PREVENTED THE DEVICE FROM POWERING ON AND WHICH IS RELATED TO THE INCIDENTS DISCUSSED WITH FDA REPRESENTATIVES IN 2009.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSTREAM XL | MKJ | PHILIPS HEALTHCARE | M4735A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |