MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2009-05-05 for RHAPSODY 101682 manufactured by Line Ind. (shanghai) Co., Ltd..
[1129011]
Patient was moving from the chair to the couch when the armrest of the chair gave way at the weld point. Patient fell, but sustained no injury.
Patient Sequence No: 1, Text Type: D, B5
[8146199]
The arm rest was returned, and the weld that secures the nut to the arm had broken. The weld appeared to be a cold weld.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006459587-2009-00002 |
| MDR Report Key | 1391682 |
| Report Source | 08 |
| Date Received | 2009-05-05 |
| Date of Report | 2009-05-04 |
| Date of Event | 2009-04-09 |
| Date Facility Aware | 2009-04-09 |
| Report Date | 2009-05-04 |
| Date Reported to FDA | 2009-05-04 |
| Date Added to Maude | 2009-09-28 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RHAPSODY |
| Generic Name | SEAT ARM REST |
| Product Code | IML |
| Date Received | 2009-05-05 |
| Returned To Mfg | 2009-05-04 |
| Model Number | 101682 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LINE IND. (SHANGHAI) CO., LTD. |
| Manufacturer Address | QING PU, SHANGHAI CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-05-05 |