MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 1996-12-31 for CHAIRMAN DENTAL CHAIR L1 00790 manufactured by Siemens Pelton & Crane.
[15448412]
It was reported by dr's office that the dr was reclining a pt in the chair when the chair back broke. The pt was jolted but there were no injuries reported by the pt or dr's office. This event did not occur during a dental procedure but during the reclining of the pt to an operating position.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-1996-00051 |
| MDR Report Key | 59723 |
| Report Source | 08 |
| Date Received | 1996-12-31 |
| Date of Report | 1996-12-30 |
| Date of Event | 1996-11-06 |
| Device Manufacturer Date | 1978-11-01 |
| Date Added to Maude | 1997-01-03 |
| 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 | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHAIRMAN DENTAL CHAIR |
| Generic Name | DENTAL OPERATORY CHAIR |
| Product Code | KLC |
| Date Received | 1996-12-31 |
| Model Number | L1 |
| Catalog Number | 00790 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 60140 |
| Manufacturer | SIEMENS PELTON & CRANE |
| Manufacturer Address | PO BOX 7800 CHARLOTTE NC 282417800 US |
| Baseline Brand Name | CHAIRMAN |
| Baseline Generic Name | DENTAL CHAIR |
| Baseline Model No | L1 |
| Baseline Catalog No | 007890 |
| Baseline ID | NA |
| Baseline Device Family | DENTAL OPERATORY WITH ACCESSORIES |
| Baseline Shelf Life Contained | A |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-12-31 |