MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-05-10 for POWERED BEACH CHAIR L05068055 * manufactured by Schuremed Corp..
[3527893]
The patient was under general anesthesia. ======================manufacturer response for schuremed beach chair positioner model 800-0004, (brand not provided) (per site reporter). ======================they are currently looking at the broken device. The manufacturer told us that recently the construction of this device has been improved to include additional safety features including extension of the support bar, padding of any piece that might touch a patients skin, and limiting movement of certain pieces. What was the original intended procedure? Shoulder repair. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3144643 |
| MDR Report Key | 3144643 |
| Date Received | 2013-05-10 |
| Date of Report | 2013-05-06 |
| Date of Event | 2013-05-01 |
| Report Date | 2013-05-06 |
| Date Reported to FDA | 2013-05-10 |
| Date Reported to Mfgr | 2013-06-04 |
| Date Added to Maude | 2013-06-04 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POWERED BEACH CHAIR |
| Generic Name | CHAIR, SURGICAL, AC-POWERED |
| Product Code | GBB |
| Date Received | 2013-05-10 |
| Returned To Mfg | 2013-05-03 |
| Model Number | L05068055 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | R |
| Device Age | 34 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SCHUREMED CORP. |
| Manufacturer Address | 50 MESSINA DRIVE BRAINTREE MA 02184 US 02184 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-10 |