MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-11-21 for CHAIRMAN L1 007890 manufactured by Siemens Pelton & Crane.
[18554057]
It was reported by the dentist that as he was raising or lowering the chairback up to the exit or operate positions, that he heard a cracking sound. Upon further investigation he found that the chair back had cracked at the lift or pusher mechanism at the base of the chair back. This event did not occur during the dental procedure but during the exiting or raising of the pt back to the upright position. The office did not report any injury as a result of this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-1996-00040 |
| MDR Report Key | 52582 |
| Date Received | 1996-11-21 |
| Date of Report | 1996-11-19 |
| Date of Event | 1996-10-15 |
| Device Manufacturer Date | 1986-01-01 |
| Date Added to Maude | 1996-12-03 |
| 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 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHAIRMAN |
| Generic Name | DENTAL OPERATORY WITH ACCESSORIES CHAIR |
| Product Code | KLC |
| Date Received | 1996-11-21 |
| Model Number | L1 |
| Catalog Number | 007890 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 10 YR |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 53224 |
| 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 | 1996-11-21 |