MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-10 for POWER PRO AMBULANCE COT 6506 6506000000 manufactured by Stryker Medical-kalamazoo.
[182805711]
It was reported that a patient was being unloaded from the ambulance. The patient was in the seated position with the fowler up and restrained by all cot restraints. The customer alleges there were two operators on the cot both on the head end of the cot. The customer stated that the patient was larger and shifted their weight to the patient left side and the cot tipped to that side. Allegedly the patient broke their wrist and an operator received a wrist sprain as a result of this incident. The cots safety bar remained caught on the safety hook of the ambulance and prevented the cot from hitting the floor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2020-00311 |
| MDR Report Key | 9813435 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-13 |
| Date Mfgr Received | 2020-02-13 |
| Device Manufacturer Date | 2015-11-30 |
| Date Added to Maude | 2020-03-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. BRIAN THOMPSON |
| 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 | POWER PRO AMBULANCE COT |
| Generic Name | STRETCHER, WHEELED |
| Product Code | FPO |
| Date Received | 2020-03-10 |
| Model Number | 6506 |
| Catalog Number | 6506000000 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 1. Required No Informationntervention | 2020-03-10 |