MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-05-15 for SCHUERCH manufactured by Schuremed.
[20234285]
Surgery pt under general anesthetic in preparation for a shoulder arthroscopy. Pt was on the berchtold b810 integrated shoulder chair. Anesthesia provider noticed the head positioning device was slightly loose after positioning the pt. When the device was further tightened with the tightening screw the aluminum bar that holds the pt's head sheared completely off from the device. The anesthesia provider had the pt's head supported at all times and consequently the pt suffered no adverse effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5030210 |
| MDR Report Key | 3121834 |
| Date Received | 2013-05-15 |
| Date of Report | 2013-05-15 |
| Date of Event | 2013-05-10 |
| Date Added to Maude | 2013-05-22 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCHUERCH |
| Generic Name | BERCHTOLD B810 INTEGRATED SHOULDER CHAIR |
| Product Code | GBB |
| Date Received | 2013-05-15 |
| Returned To Mfg | 2013-05-13 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SCHUREMED |
| Manufacturer Address | 50 BRAINTREE DR. MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-05-15 |