FDA Adverse Event
Summary report: N
MECHANICAL CHAIR/TRANSPORT CHAIR
MDR report key: 3013809
·
Received March 20, 2013
Report
- Report Number
- 1531186-2013-01166
- Date Received
- March 20, 2013
- Report Date
- February 20, 2013
- Manufacturer
- GOODBABY
- Product Code
- INM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ONLY ONE MDR REPORT WILL BE SUBMITTED FOR THIS EVENT, ALTHOUGH FOUR DIFFERENT COMPLAINTS WERE CREATED BECAUSE OF DIFFERENT PARTS NEEDED TO REPAIR THE UNIT, AND THE FILE NUMBERS ARE THE FOLLOWING: (B)(4).
Description of Event or Problem · 1
(B)(4) THE DEALER REPORTED THAT THE (B)(4) 3-POSITION RECLINER REAR CASTERS WERE NOT LOCKING, AND BOTH ARM RESTS WERE REPLACED. THERE WAS NO INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 115599 | MECHANICAL CHAIR/TRANSPORT CHAIR | 890.3100 | INM | GOODBABY | IH6065A/IH60 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |