FDA Adverse Event
Malfunction
Summary report: N
PRESSURE FIT (2 POST)
MDR report key: 3829798
·
Received May 6, 2014
Report
- Report Number
- 3007802293-2014-00005
- Event Type
- Malfunction
- Date Received
- May 6, 2014
- Date of Event
- April 6, 2014
- Report Date
- May 2, 2014
- Manufacturer
- PRISM MEDICAL
- Product Code
- FSA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE ROOT CAUSE OF THIS PROBLEM IS THAT THE DEALER LACKED COMPETENCE TO SET-UP THE PRESSURE FIT SYSTEM. HE DID NOT ACHIEVE SAFE INSTALLATION PRESSURE. AS A CORRECTIVE ACTION, THE DEALER WAS RETRAINED.
Description of Event or Problem · 1
FREE STANDING TRACK WAS INSTALLED IMPROPERLY, RESULTING IN THE SYSTEM COLLAPSING ON A PT WHILE GETTING TRANSFERRED INTO BED. THE PT REPORTED SACRAL WOUND BLEEDING, CATHETER TRAUMA, AND BROKEN EYE GLASSES. A COMPLAINT THAT A PRESSURE FIT TRACK SYSTEM HAD COLLAPSED WHEN IN USE WAS RECEIVED. THE DEALER RETURNED TO THE CLIENT'S HOME TO RE-SETUP THE SYSTEM CORRECTLY. ENGINEERING ALSO CONFIRMED THE SYSTEM WHICH COLLAPSED HAD ALL WARNING LABELS APPLIED, WHICH SHOW THE RANGE OF SAFE AND UNSAFE INSTALLATION PRESSURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 270236 | PRESSURE FIT (2 POST) | PRESSURE FIT 2 POST | FSA | PRISM MEDICAL | 341500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR |