MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-09-09 for PATIENT SCALE 59011A manufactured by Ims, Inc.
[25336407]
Joerns sending the report to the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[25336428]
It was reported to the manufacturer by the end user, per the end user patient was in a power chair and the nurse attached sling to cradle and lifted her up and proceeded to move the lift. The nut came off the bolt and she fell straight to the floor. She was in the highest position. The cradle seems to have come apart. The resident sustained a fractured hip and required surgery. (b)(4) were entered into our system to have the lift, including the cradle and scale, returned to joerns for investigation. The lift, including the cradle and scale, was received at joerns on 09/08/2015 and is awaiting investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009402404-2015-00027 |
| MDR Report Key | 5066614 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-09-09 |
| Date of Report | 2015-09-09 |
| Date of Event | 2015-08-15 |
| Device Manufacturer Date | 2003-07-08 |
| Date Added to Maude | 2015-09-09 |
| 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 | FELICIA BANKS |
| Manufacturer Street | 2100 DESIGN ROAD |
| Manufacturer City | ARLINGTON TX 76014 |
| Manufacturer Country | US |
| Manufacturer Postal | 76014 |
| Manufacturer Phone | 8008260270 |
| Manufacturer G1 | IMS, INC |
| Manufacturer Street | 1104 HEINZ DRIVE UNIT B |
| Manufacturer City | EAST DUNDEE IL 60118 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60118 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PATIENT SCALE |
| Generic Name | PATIENT SCALE |
| Product Code | FRW |
| Date Received | 2015-09-09 |
| Model Number | 59011A |
| Catalog Number | 59011A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMS, INC |
| Manufacturer Address | 1104 HEINZ DRIVE UNIT B EAST DUNDEE IL 60118 US 60118 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2015-09-09 |