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).
[1359595]
It was reported to manufacturing by the distributor via the facility. Per the facility the resident was put in the sling and the sling was attached to the lift, they had just started to do the transfer when the lift broke, they heard a snap and the cradle to the scale broke causing the resident to fall back on the bed and the lift cradle fell onto her resulting in the injury. The facility and doctor assessed the resident and she was complaining of pain in the chest, shoulder and the knees, the resident rated her pain on a scale from 1 to 10 as an 8. The distributor issued and ra to have the scale and cradle returned, however, they changed their mind and legal council was retained, they will not release the components in question.
Patient Sequence No: 1, Text Type: D, B5
[8586360]
Investigation: telephone conferences continuing, testing continuing to duplicate the failure mode. (b)(6) doing a recall of all units in the field.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1317256-2010-00003 |
| MDR Report Key | 1780897 |
| Report Source | 00 |
| Date Received | 2010-07-23 |
| Date of Report | 2010-07-22 |
| Date of Event | 2010-06-08 |
| Date Mfgr Received | 2010-06-09 |
| Device Manufacturer Date | 2010-01-01 |
| 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 |
| Model Number | HPL700 W/SCALE |
| Catalog Number | HPL700/WSC |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 |