FDA Adverse Event
Malfunction
Summary report: N
XMAX MOTOR
MDR report key: 3061283
·
Received April 10, 2013
Report
- Report Number
- 1045834-2013-01365
- Event Type
- Malfunction
- Date Received
- April 10, 2013
- Date of Event
- March 12, 2013
- Report Date
- March 13, 2013
- Manufacturer
- THE ANSPACH EFFORT, INC.
- Product Code
- ERL
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RECEIVED BY ANSPACH. IF ADD'L INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).
Description of Event or Problem · 1
REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE'S "HOSE BLEW UP" DURING A CRANIOTOMY PROCEDURE. THE HOSE BLEW UP APPROX 1.5 INCHES FROM THE HAND PIECE. THERE WAS AN APPROXIMATE 10 MINUTE DELAY TO RETRIEVE ANOTHER DRILL. THERE WERE NO INJURIES TO THE PT OR THE USER. THE FACILITY FILED AN INCIDENT REPORT, BUT WOULD NOT PROVIDE IT. THERE WAS NO ADD'L INFO PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 153783 | XMAX MOTOR | ERL | THE ANSPACH EFFORT, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |