MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-03-30 for BEACH CHAIR POSITIONER manufactured by Skytron.
[20779794]
Beach chair positioner (skytron). Patient placed on hercules operating room bed, with the beach chair attachment securely and properly attached. The attachment broke in the lower back portion of the composite board (totally across device) and metal supporting bars prior to the initiation of anesthesia. The patient slid off head first towards the operating room floor. The patient's head and neck was supported by operating room staff but patient fell to the floor with contact affecting the upper back and bilateral shoulders. Post event, the patient complained of left shoulder pain, no injury determined at that time. Device reported weight limit (b)(6), patient confirmed and verified weight (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5041907 |
| MDR Report Key | 4664984 |
| Date Received | 2015-03-30 |
| Date of Report | 2015-03-30 |
| Date of Event | 2015-03-18 |
| Date Added to Maude | 2015-04-08 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | BEACH CHAIR POSITIONER |
| Generic Name | BEACH CHAIR POSITIONER |
| Product Code | GBB |
| Date Received | 2015-03-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SKYTRON |
| Manufacturer Address | GRAND RAPIDS MI 49512 US 49512 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-30 |