MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2011-12-03 for HOYER STATURE 4PT CRADLE SCALE STATURE/4PTWCS manufactured by Apex Healthcare Mfg Inc.
[2569650]
It was reported to the mfr as told by (b)(4) via the facility, that the following occurred on (b)(6) 2011, while using the hoyer stature 4pt cradle with scale. Per (b)(4) their customer reported that their lift broke while transferring a pt. The pt was over her bed when the failure occurred and sustained no injuries. The serial number of the lift was in an earlier recall z-0921-2007. Mfr confirmed recall documents were sent to dealer; however, it is unk if the dealer followed through with their recall responsibilities. The cradle and scale has been replaced and ra (b)(4) has been issued to obtain the device for eval.
Patient Sequence No: 1, Text Type: D, B5
[9602571]
Joerns is sending report to scale mfr on (b)(4) 2011. The scale mfr is (b)(4). The lift mfr is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2182305-2011-00046 |
| MDR Report Key | 2409929 |
| Report Source | 08 |
| Date Received | 2011-12-03 |
| Date of Report | 2011-12-02 |
| Date of Event | 2011-11-02 |
| Date Facility Aware | 2011-11-02 |
| Report Date | 2011-12-02 |
| Date Mfgr Received | 2011-11-02 |
| Device Manufacturer Date | 2005-12-01 |
| Date Added to Maude | 2012-03-05 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CONNIE HANNON-RABEL |
| Manufacturer Street | 5001 JOERNS DR. |
| Manufacturer City | STEVENS POINT WI 54481 |
| Manufacturer Country | US |
| Manufacturer Postal | 54481 |
| Manufacturer Phone | 7153413600 |
| Manufacturer G1 | APEX HEALTHCARE MFG INC |
| Manufacturer Street | NO 20 INDUSTRIAL 3RD TOU CHIAC INDUSTRIAL PARK |
| Manufacturer City | MIN HSIUNG, CHI YI |
| Manufacturer Country | CH |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | Z-0921-2007 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOYER STATURE 4PT CRADLE SCALE |
| Generic Name | PATIENT LIFT WITH SCALE |
| Product Code | FRW |
| Date Received | 2011-12-03 |
| Model Number | STATURE/4PTWCS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APEX HEALTHCARE MFG INC |
| Manufacturer Address | MIN HSIUNG, CHI YI CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-03 |