MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 1997-11-05 for CHAIRMAN DENTAL CHAIR L1 007890 manufactured by Siemens Pelton & Crane.
[16275235]
Pelton & crane rec'd a call from a dist svc technician regarding a chairman dental chair that broke. The technician told co that the dr had a pt in the chairman chair and the pt pushed with his feet against the floor causing the seat assembly to detach from the base of the chair. The dr caught the pt before he fell. There were no injuries reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-1997-00126 |
| MDR Report Key | 131372 |
| Report Source | 08 |
| Date Received | 1997-11-05 |
| Date of Report | 1997-11-05 |
| Date Mfgr Received | 1997-10-06 |
| Device Manufacturer Date | 1984-01-01 |
| Date Added to Maude | 1997-11-14 |
| 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 | SERVICE PERSONNEL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHAIRMAN DENTAL CHAIR |
| Generic Name | DENTAL OPERATORY CHAIR |
| Product Code | KLC |
| Date Received | 1997-11-05 |
| Model Number | L1 |
| Catalog Number | 007890 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 128408 |
| 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 | 1997-11-05 |