MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-05 for ZOOM STRETCHER, PRIME X 1125 1125000000X manufactured by Stryker Medical-kalamazoo.
[177843595]
It was reported that the drive wheel disengaged while in use, so the trolley went into manual steer (zoom disengages during use). The porter stopped the trolley by leaning backwards to slow it, but it lightly hit the doors before stopping. The porter immediately experienced back pain, and was absent from work due to this.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2020-00299 |
| MDR Report Key | 9672556 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-05 |
| Date of Event | 2019-07-01 |
| Date Mfgr Received | 2020-01-27 |
| Date Added to Maude | 2020-02-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MR. KRISTEN CANTER |
| Manufacturer Street | 3800 EAST CENTRE AVENUE |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal | 49002 |
| Manufacturer Phone | 2693292100 |
| Manufacturer G1 | STRYKER MEDICAL-KALAMAZOO |
| Manufacturer Street | 3800 EAST CENTRE AVENUE |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZOOM STRETCHER, PRIME X |
| Generic Name | STRETCHER, WHEELED, POWERED |
| Product Code | INK |
| Date Received | 2020-02-05 |
| Model Number | 1125 |
| Catalog Number | 1125000000X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER MEDICAL-KALAMAZOO |
| Manufacturer Address | 3800 EAST CENTRE AVENUE PORTAGE MI 49002 US 49002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-05 |