FDA Adverse Event
Malfunction
Summary report: N
NEURO ADAPTER
MDR report key: 591918
·
Received July 15, 2004
Report
- Report Number
- 1221538-2004-00002
- Event Type
- Malfunction
- Date Received
- July 15, 2004
- Report Date
- June 18, 2004
- Manufacturer
- ALLEN MEDICAL SYSTEMS, INC.
- Product Code
- FWZ
- Removal / Correction Number
- 2004-038
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THIS DEVICE IS INSTALLED IN THE FRAME OF A SURGICAL BED AND ALLOWS PT HEADREST DEVICE TO BE ATTACHED TO THE SURGICAL BED. THE DEVICE DISTRIBUTOR REPORTED THAT A USER INFORMED THEM THAT ONE OF THE DEVICES BECAME LOOSE DURING A PROCEDURE. SUBSEQUENT EXAMINATION OF THE DEVICE BY A MECHANICAL ENGINEER OF ALLEN MEDICAL SYSTEMS (THE MANUFACTURER) CONFIRMED THAT THE CLAMPING PORTION OF THE DEVICE HAD BEEN INCORRECTLY ADJUSTED DURING MANUFACTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEURO ADAPTER | PATIENT POSITIONING DEVICE | FWZ | ALLEN MEDICAL SYSTEMS, INC. | F-MDTNA2-A1 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |