MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-25 for BEACH CHAIR 800-0142 manufactured by Schuerch Corporation.
[75941532]
Patient Sequence No: 1, Text Type: N, H10
[75941533]
Beach chair positioner was previously out for repair because of a broken back. Biomedical engineering replaced this broken part and returned positioner to the operating room (or). This beach chair positioner was placed back in service and was used for the 1st time since this repair. After positioning the patient on the o. R. Table with the beach chair positioner on the table, the nurse and surgeon noticed the replacement part was placed in the wrong position. The patient was moved off the or table to the stretcher, the staff removed the beach chair positioner, and put our 2nd beach chair positioner on the o. R. Table, and then moved the patient back to the or table. The 1st beach chair positioner was tagged and taken out of service and given to biomed to examine and fix. The biomed. Director reported his tech installed the two brackets on opposite sides and upside down. Manufacturer response for positioning aide, beach chair (per site reporter): biomed. Dept. Contacted manufacturer with a suggestion to look into the design with the goal that it not possible to have the parts appear to fit together properly when assembled. Not sure of the actual response.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6590295 |
| MDR Report Key | 6590295 |
| Date Received | 2017-05-25 |
| Date of Report | 2017-05-12 |
| Date of Event | 2017-03-06 |
| Report Date | 2017-05-12 |
| Date Reported to FDA | 2017-05-12 |
| Date Reported to Mfgr | 2017-05-12 |
| Date Added to Maude | 2017-05-25 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BEACH CHAIR |
| Generic Name | CHAIR, SURGICAL, AC-POWERED |
| Product Code | GBB |
| Date Received | 2017-05-25 |
| Model Number | 800-0142 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SCHUERCH CORPORATION |
| Manufacturer Address | 452 RANDOLPH STREET ABINGTON MA 02351 US 02351 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-25 |