FDA Adverse Event
Malfunction
Summary report: N
PERMOBIL
MDR report key: 3772301
·
Received March 26, 2014
Report
- Report Number
- 1221084-2014-00005
- Event Type
- Malfunction
- Date Received
- March 26, 2014
- Date of Event
- February 27, 2014
- Report Date
- March 26, 2014
- Manufacturer
- PERMOBIL INC.
- Product Code
- ITI
- PMA / PMN Number
- K103477
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DHR FOR S/N (B)(4) WAS REVIEWED, CHAIR MET ALL SPECIFICATIONS BEFORE DISTRIBUTION. THE RECLINE ACTUATOR HAS BEEN RETURNED TO THE COMPONENT SUPPLIER FOR EVALUATION. A NEW ACTUATOR WAS INSTALLED ON THE CLIENTS CHAIR AND IS WORKING AS INTENDED. IF MORE INFORMATION IS OBTAINED FROM OUR INVESTIGATION WE WILL SUBMIT A FOLLOW UP REPORT.
Description of Event or Problem · 1
CLIENT REPORTS THE BACKREST OF THE CHAIR FELL BACK LEAVING HIM LAYING FLAT. NO INJURY WAS SUSTAINED BUT HE WAS NOT ABLE TO OPERATE THE CHAIR OR SIT UP WITHOUT ASSISTANCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 177974 | PERMOBIL | POWER WHEELCHAIR | ITI | PERMOBIL INC. | M300 C3G |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |