FDA Adverse Event
Malfunction
Summary report: N
BASIC CONFIGURATION MODEL 1105
MDR report key: 2890638
·
Received November 21, 2012
Report
- Report Number
- 1831750-2012-12173
- Event Type
- Malfunction
- Date Received
- November 21, 2012
- Date of Event
- October 12, 2012
- Report Date
- October 26, 2012
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
IV POLE. MFR'S INVESTIGATION IS ONGOING. IF ADD'L INFO IS REC'D, A F/U REPORT MAY BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE IV POLE HAD MALFUNCTIONED. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BASIC CONFIGURATION MODEL 1105 | HOSPITAL WHEELED STRETCHER | FPO | STRYKER MEDICAL | 1105 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |