MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-10-24 for TRAPEZE FLOOR STAND - DEVICE #1 IC-7741 FLOOR STAND manufactured by Sunrise Medical.
[519869]
It was reported to mfr, by facility and reporter, per facility they have a 325 lb man using the trapeze for bed mobility / repositioning and not supporting his 325 lb weight. The trapeze triangle was on the floor when they found it, and the resident stated that it hit him in the head, resident did have a bump to his head. Facility also said the state was in and they did a state incident report on this. Per mfr in our user instruction manual, it states under the warnings "the head trapeze, used in conjunction with a bed, can support an individual weighing up to 250 lbs. " facility is stating because we do not have a label on the triangle itself and because we state "can support" and "assists the user when repositioning in bed" facility wants to know what do we mean by that verbage. Facility insists we are not clear, and because the pt was using it for bed mobility / repositioning and not supporting his 325 lbs, they want something in writing from us. Per mfg this is in question; because we believe when a person is repositioning or using a trapeze for bed mobility you are supporting/ utilizing your weight. Per product manager, if the trapeze is properly installed and the triangle locked down, per the mfr installation instructions, there is no way for it to fall off.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182305-2006-00038 |
| MDR Report Key | 773538 |
| Report Source | 06 |
| Date Received | 2006-10-24 |
| Date of Report | 2006-10-16 |
| Date of Event | 2006-09-23 |
| Date Facility Aware | 2006-09-23 |
| Report Date | 2006-10-16 |
| Date Mfgr Received | 2006-09-25 |
| Date Added to Maude | 2006-10-27 |
| 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 | SHERYL NUGENT |
| Manufacturer Street | 5001 JOERNS DR. |
| Manufacturer City | STEVENS POINT WI 54481 |
| Manufacturer Country | US |
| Manufacturer Postal | 54481 |
| Manufacturer Phone | 7153413600 |
| Manufacturer G1 | SUNRISE MEDICAL |
| Manufacturer Street | 5001 JOERNS DR. |
| Manufacturer City | STEVENS POINT WI 54481 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 54481 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRAPEZE FLOOR STAND - DEVICE #1 |
| Generic Name | TRAPEZE FLOOR STAND BED ACCESSORY |
| Product Code | ILZ |
| Date Received | 2006-10-24 |
| Model Number | IC-7741 FLOOR STAND |
| Catalog Number | IC-7741 FLOOR STAND |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNK |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 761322 |
| Manufacturer | SUNRISE MEDICAL |
| Manufacturer Address | 5001 JOERNS DR. STEVENS POINT WI 54481 US |
| Baseline Brand Name | TRAPEZE FLOOR STAND - DEVICE #1 |
| Baseline Generic Name | TRAPEZE FLOOR STAND BED ACCESSORY |
| Baseline Model No | IC-7741 FLOOR S |
| Baseline Catalog No | IC-7741 FLOOR STAND |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-10-24 |