FDA Adverse Event
Malfunction
Summary report: N
T4 POWER PACK
MDR report key: 5004494
·
Received August 14, 2015
Report
- Report Number
- 0001811755-2015-02929
- Event Type
- Malfunction
- Date Received
- August 14, 2015
- Date of Event
- July 20, 2015
- Report Date
- July 20, 2015
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- FXZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS SCRAPPED BY STRYKER.
Description of Event or Problem · 1
IT WAS REPORTED THAT AT THE USER FACILITY THE DEVICE WAS OVERHEATING. THE USER FACILITY WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THE REPORTED EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 539334 | T4 POWER PACK | HELMET, SURGICAL | FXZ | STRYKER INSTRUMENTS-KALAMAZOO | 14318 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |