MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 1997-05-30 for AMBER-CU 104L001 manufactured by Oldelft B.v..
[16290460]
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. Subsequently during service the arm descended another 10 cm. Subsequent investigation indicated that the maintenance procedure for the regular check on the lifting mechanism had not been performed as required by the maintenance instructions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1180516-1997-00002 |
| MDR Report Key | 96422 |
| Report Source | 01,08 |
| Date Received | 1997-05-30 |
| Date of Report | 1997-05-30 |
| Date of Event | 1997-01-17 |
| Date Mfgr Received | 1997-02-06 |
| Device Manufacturer Date | 1991-08-01 |
| 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 | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMBER-CU |
| Generic Name | CLINICAL CHESTS STAND (UPRIGHT) |
| Product Code | KPX |
| Date Received | 1997-05-30 |
| Model Number | AMBER-CU |
| Catalog Number | 104L001 |
| 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 | 76896 |
| Manufacturer | OLDELFT B.V. |
| Manufacturer Address | RONTGENWEG 1 DELFT NL 2624 BD |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-05-30 |