MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-02-06 for CHAIRMAN DENTAL CHAIR L1 007890 manufactured by Siemens Pelton & Crane.
[42501]
It was reported by the dr's office that the dr was reclining a pt in a dental chair when the chair back made a "loud pop noise". The dr continued to use the chair and three weels later the chair back broke while reclining a pt. The chair back fell on the hygienists lap. This event did not occur during a dental procedure but during the reclinig of the pt to an operating position. There were no injuries reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-1997-00064 |
| MDR Report Key | 67226 |
| Report Source | 05 |
| Date Received | 1997-02-06 |
| Date of Report | 1997-02-06 |
| Date of Event | 1997-01-09 |
| Device Manufacturer Date | 1986-11-01 |
| Date Added to Maude | 1997-02-10 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | RP |
| 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 | 1997-02-06 |
| Model Number | L1 |
| Catalog Number | 007890 |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 67262 |
| 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 | 1997-02-06 |