MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 1997-04-23 for SPIRIT S1 Z 538 5161596 manufactured by Siemens Pelton P Crane.
[15484759]
A patient was in a dental chair when the chairs articulating head rest slid down causing the patients head to rotate backwards. No injuries were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-1997-00083 |
| MDR Report Key | 86569 |
| Report Source | 01,07 |
| Date Received | 1997-04-23 |
| Date of Report | 1997-04-23 |
| Date of Event | 1997-03-24 |
| Device Manufacturer Date | 1996-10-01 |
| Date Added to Maude | 1997-04-28 |
| 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 | SPIRIT S1 |
| Generic Name | DENTAL OPERATORY CHAIR W/DELIVERY UNIT |
| Product Code | KLC |
| Date Received | 1997-04-23 |
| Model Number | Z 538 |
| Catalog Number | 5161596 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 85755 |
| Manufacturer | SIEMENS PELTON P CRANE |
| Manufacturer Address | P.O. BOX 7800 CHARLOTTE NC 282417800 US |
| Baseline Brand Name | SPIRIT S1 |
| Baseline Generic Name | DENTAL CHAIR WITH DELIVERY SYSTEM |
| Baseline Model No | Z 538 |
| Baseline Catalog No | 5161596 |
| Baseline ID | NA |
| Baseline Device Family | SPIRIT |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K962071 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-04-23 |