MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 1997-02-06 for CHAIRMAN DENTAL CHAIR L1 007890 manufactured by Siemens Pelton & Crane.
[43335]
It was reported by a distributor service technician that a chair mount kit, which allows for the installation of a delivery unit for an operatory, came apart at the connection to the chair and the delivery unit fell towards the pt. However, the pt caught it dental procedure but during the lifting of the pt to an operating position.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-1997-00062 |
| MDR Report Key | 67221 |
| Report Source | 08 |
| Date Received | 1997-02-06 |
| Date of Report | 1997-02-06 |
| Date of Event | 1997-01-08 |
| 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 |
| 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 | * |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 67257 |
| 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 |