MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2010-07-23 for HOYER LIFT W/SCALE HPL700 W/SCALE HPL700/WSC manufactured by Sr Instruments, Inc. (scale Manufacturer Only).
[20957363]
It was reported to manufacturing by the distributor via the facility. Using the replacement pt lifter sent, the same area failed ie the bolt/pin coming up through the cradle to the scale broke, causing the assembly to tilt and then a dog ear piece broke off resulting in this fall. The pt fell back onto the bed, however, the pt was injured when the cradle landed on top of her resulting in the injury, ra issued for the return of parts. The distributor issued a capa (b)(4) to the manufacturer.
Patient Sequence No: 1, Text Type: D, B5
[21233666]
Investigation: telephone conferences were initiated between (b)(6) and sr instruments. Testing initiated trying to reproduce the mode of failure, to determine if the device was used properly or as intended. Sr instruments doing material testing, verified steels heat treating processes and verified material type. (b)(4) performing safety performance testing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1317256-2010-00002 |
| MDR Report Key | 1780899 |
| Report Source | 00 |
| Date Received | 2010-07-23 |
| Date of Report | 2010-07-22 |
| Date of Event | 2010-04-23 |
| Date Mfgr Received | 2010-05-11 |
| Device Manufacturer Date | 2010-03-01 |
| Date Added to Maude | 2012-03-15 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 600 YOUNG ST. |
| Manufacturer City | TONAWANDA NY 14150 |
| Manufacturer Country | US |
| Manufacturer Postal | 14150 |
| Manufacturer Phone | 7166935977 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOYER LIFT W/SCALE |
| Generic Name | PATIENT LIFTER W/SCALE |
| Product Code | FRW |
| Date Received | 2010-07-23 |
| Returned To Mfg | 2001-05-19 |
| Model Number | HPL700 W/SCALE |
| Catalog Number | HPL700/WSC |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SR INSTRUMENTS, INC. (SCALE MANUFACTURER ONLY) |
| Manufacturer Address | 600 YOUNG ST. TONAWANDA NY 14150 US 14150 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2010-07-23 |