MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-05-18 for VANDERLIFT WITH SCALE VANDERLIFT W/SCALE SCALE FG859VS manufactured by Sr Instruments, Inc..
[16730537]
It was reported to the lift mfr by the nursing home that a malfunction occurred involving a broken hook on the scale attached to the lifter. It was reported that the scale was not in use and no pt or staff were injured. Pictures were sent to the lift manufacturer by the nursing home,
Patient Sequence No: 1, Text Type: D, B5
[17044633]
Sr asked for the return of the scale to the lift mfr and they reported that the nursing home was not responding to their request. We then asked the lift mfr if he had any more correspondence with the nursing home and the nursing home's response was no casualties, no one was hurt. The scale "broke". A malfunction was reported. Pictures were sent to the lift mfr by the nursing home, the pictures show the scale with the broken hook laying next to it. Missing from the picture was a screw that is used in the hook and a plastic insert that is added by the lift mfr before shipping to the customer. This plastic insert if not used could have caused the misuse of the scale.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1317256-2012-00003 |
| MDR Report Key | 2617378 |
| Report Source | 06 |
| Date Received | 2012-05-18 |
| Date of Report | 2012-05-14 |
| Date of Event | 2012-03-12 |
| Date Mfgr Received | 2012-04-12 |
| Device Manufacturer Date | 1999-01-01 |
| Date Added to Maude | 2012-09-25 |
| 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 | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VANDERLIFT WITH SCALE |
| Generic Name | PATIENT LIFT WITH SCALE |
| Product Code | FRW |
| Date Received | 2012-05-18 |
| Model Number | VANDERLIFT W/SCALE |
| Catalog Number | SCALE FG859VS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SR INSTRUMENTS, INC. |
| Manufacturer Address | 600 YOUNG ST. TONAWANDA NY 14150 US 14150 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-05-18 |