MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-03-13 for COACHMAN II DENTAL CHAIR CH2 manufactured by Pelton/crane Co..
[19551580]
On 11/16/95 when rptr's hygienist was seating her pt the chair came down on her foot. She was trapped in this position, due to no override, for 18 minutes, resulting in a broken foot. Rptr contacted 911 to have ems unit help extricate the foot. Her hygienist missed work for almost 3 months because of this event. It is rptr's contention that the chair is unsafe because the base comes too close to the floor. There is a foot control pedal that, if it ends up directly beneath the base, can trap the foot. Once trapped in "down" position there is no mechanism by which to bypass this. On monday, 11/27/95, a mfr's rep came to rptr's office to test the chair. He agreed that there was a problem with the chair and it was a matter that needed to be examined further. He was told the mfr would contact him. They never did.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1008605 |
| MDR Report Key | 31182 |
| Date Received | 1996-03-13 |
| Date of Report | 1996-03-11 |
| Date of Event | 1995-11-16 |
| Date Added to Maude | 1996-03-18 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COACHMAN II DENTAL CHAIR |
| Generic Name | PATIENT DENTAL CHAIR |
| Product Code | KLC |
| Date Received | 1996-03-13 |
| Model Number | CH2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 32252 |
| Manufacturer | PELTON/CRANE CO. |
| Manufacturer Address | 11727 FRUEHAUF DR. CHARLOTTE NC 28273 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1996-03-13 |