MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-09-13 for LIFESTAND MOBILE ROLL LIFEPAK 12 LIFESTAND MOBILE ROLL N/A manufactured by Physio-control.
[2881792]
A nurse was pushing the portable ekg monitor mobile stand back to the location where it is stored when a wheel from the mobile stand fell off and the portable ekg machine lurched forward and fell to the floor. The nurse noticed that a second wheel was almost detached from the cart. Biomedical engineering reinstalled the wheels and also inspected the wheels on a second mobile stand on the unit. The portable ekg machine required a minor repair and was tested and placed back in service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2749397 |
| MDR Report Key | 2749397 |
| Date Received | 2012-09-13 |
| Date of Report | 2012-09-12 |
| Date of Event | 2012-08-21 |
| Report Date | 2012-09-12 |
| Date Reported to FDA | 2012-09-13 |
| Date Added to Maude | 2012-09-18 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFESTAND MOBILE ROLL |
| Generic Name | LIFCART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT) |
| Product Code | BZN |
| Date Received | 2012-09-13 |
| Model Number | LIFEPAK 12 LIFESTAND MOBILE ROLL |
| Catalog Number | N/A |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | * |
| Device Age | 7 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHYSIO-CONTROL |
| Manufacturer Address | 11811 WILLOW RD NE REDMOND WA 98052 US 98052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-09-13 |