MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-03 for 1089 1089-000-000 manufactured by Stryker Corporation.
[177368017]
Surgeon was in the middle of performing a membrane peel during his retinal procedure. During the procedure the headrest of the stretcher dropped slightly as they were working. Surgery was stopped to recheck headrest. Pressure applied to headrest to check and no further movement was noted. Patient went to recovery. When patient was awake, the stretcher was removed and tagged for facilities to inspect. Surgeon did say patient had some bleeding in the eye as a result. It would be several weeks before he will know the full outcomes. It was noted upon inspection that it is possible for mechanism of the headrest to be between "notches" of adjustment. When this occurs, only a small amount of pressure is needed to lock headrest into the next level of adjustment. Manufacturer response for stretcher, wheeled, na (per site reporter). Stryker was contacted to investigate and repair stretcher. The rep was present at the hospital and noticed a gap where two pieces come together on the head piece. A new head piece was ordered to replace current head piece. We are awaiting an official report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9659228 |
| MDR Report Key | 9659228 |
| Date Received | 2020-02-03 |
| Date of Report | 2019-11-21 |
| Date of Event | 2019-11-12 |
| Report Date | 2019-11-21 |
| Date Reported to FDA | 2019-11-21 |
| Date Reported to Mfgr | 2020-02-03 |
| Date Added to Maude | 2020-02-03 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NA |
| Generic Name | STRETCHER, WHEELED |
| Product Code | FPO |
| Date Received | 2020-02-03 |
| Model Number | 1089 |
| Catalog Number | 1089-000-000 |
| Device Availability | Y |
| Device Age | 8 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER CORPORATION |
| Manufacturer Address | 2825 AIRVIEW BLVD PORTAGE MI 49002 US 49002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-03 |