FDA Adverse Event
Malfunction
Summary report: N
HEARTSTREAM XLT
MDR report key: 1250834
·
Received November 25, 2008
Report
- Report Number
- 1218950-2008-00651
- Event Type
- Malfunction
- Date Received
- November 25, 2008
- Report Date
- October 29, 2008
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K992543
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER REPORTED THAT THE BATTERY WOULD NOT STAY INSERTED INTO THE DEVICE. THE COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED, UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE BATTERY WOULD NOT STAY INSERTED INTO THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSTREAM XLT | MKJ | PHILIPS MEDICAL SYSTEMS | M3500B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |