MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1997-05-30 for AMBER-AU 104M001 manufactured by Oldelft B.v..
[63997]
As a result of wear in lifting mechanism the horizontal arm of the device moved down for approx. 10 cm. No pt injuries are reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1180516-1997-00001 |
| MDR Report Key | 96425 |
| Report Source | 06 |
| Date Received | 1997-05-30 |
| Date of Report | 1997-05-29 |
| Date of Event | 1994-01-10 |
| Device Manufacturer Date | 1991-10-01 |
| Date Added to Maude | 1997-06-09 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMBER-AU |
| Generic Name | CLINICAL CHEST STAND (UPRIGHT) |
| Product Code | KPX |
| Date Received | 1997-05-30 |
| Model Number | AMBER-AU |
| Catalog Number | 104M001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 95197 |
| Manufacturer | OLDELFT B.V. |
| Manufacturer Address | RONTGENWEG 1 2624 BD DELFT, THE NETHERLANDS NL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-05-30 |