MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-20 for STAIR PRO - MODEL 6252 6252000000 manufactured by Stryker Medical-kalamazoo.
[120976762]
The landing gear of the caterpillar (stair pro) is blocked, which makes climbing stairs impossible. No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
Patient Sequence No: 1, Text Type: D, B5
[131584152]
Information provided by the user facility reported that the device was blocked with dirt/debris.
Patient Sequence No: 1, Text Type: N, H10
[131584153]
The landing gear of the caterpillar (stair pro) is blocked, which makes climbing stairs impossible. No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2018-01049 |
| MDR Report Key | 7893180 |
| Date Received | 2018-09-20 |
| Date of Report | 2018-10-04 |
| Date of Event | 2018-08-23 |
| Date Mfgr Received | 2018-08-24 |
| Device Manufacturer Date | 2018-01-02 |
| Date Added to Maude | 2018-09-20 |
| 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. 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 | 0 |
| Brand Name | STAIR PRO - MODEL 6252 |
| Generic Name | STRETCHER, HAND-CARRIED |
| Product Code | FPP |
| Date Received | 2018-09-20 |
| Catalog Number | 6252000000 |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2018-09-20 |