MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2010-06-05 for HALF POWER SUPERSTAND STANDUP WHEELCHAIR HPS-2 manufactured by The Standing Company.
[1536432]
Pt's mom called in and said that her son, pt: (b) (6), fell out of his standing wheelchair (model: hps-2, (b) (4)), and hit his head.
Patient Sequence No: 1, Text Type: D, B5
[8548368]
Device was returned to our facility on 06/12/2008. Device was inspected. Recreation of event on (b) (6) 2008 at device mfg facility. Upon investigation, it was noted that the set screw on the arm swivel housing, which is loctited, the loctite does not adhere properly once arm assembly is installed with grease. Device was replaced with new arm assembly. Corrective action was generated from investigation. Device was returned to pt (b) (6) in (b) (6) 2008, where he was able to continue use of the chair. Issue was resolved.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007494904-2008-00001 |
| MDR Report Key | 1712829 |
| Report Source | 04 |
| Date Received | 2010-06-05 |
| Date of Report | 2010-06-02 |
| Date of Event | 2008-06-04 |
| Date Mfgr Received | 2008-06-04 |
| Device Manufacturer Date | 2006-10-01 |
| Date Added to Maude | 2010-06-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 5848 DIXIE HIGHWAY |
| Manufacturer City | SAGINAW MI 486015967 |
| Manufacturer Country | US |
| Manufacturer Postal | 486015967 |
| Manufacturer Phone | 9897469100 |
| Manufacturer G1 | THE STANDING COMPANY |
| Manufacturer Street | 5848 DIXIE HIGHWAY |
| Manufacturer City | SAGINAW MI 48601596 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 48601 5967 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HALF POWER SUPERSTAND STANDUP WHEELCHAIR |
| Generic Name | STANDUP WHEELCHAIR |
| Product Code | IPL |
| Date Received | 2010-06-05 |
| Returned To Mfg | 2008-06-12 |
| Model Number | HPS-2 |
| Catalog Number | HPS-2 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THE STANDING COMPANY |
| Manufacturer Address | 5848 DIXIE HIGHWAY SAGINAW MI 48601 US 48601 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-06-05 |