MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-12-08 for BURKE TRI-FLEX II manufactured by Burke, Inc..
[55574549]
Investigation: alleged injuries. Pt's wife left facility day of incident without reporting incident or injuries. The next day facility received verbal report of incident and injuries, pain to wife's back, left elbow and shoulder. She had later been taken to the hospital and received medication for pain relief. Pt has left facility. Facility has not received f/u info or a documented medical report. Alleged report of bed collapsing. Report of bed transport axle being down out of proper use position (up). Tests of identical beds show. With transport axles not in normal retracted position and pin not in locking position, the axle could rotate and bed could drop on one side 1. 5 to 2 inches onto the corner casters. With the person sitting on the mattress a drop of two inches would not likely result in the reported injuries. There is speculation that they could have fallen off the bed and on to the floor. When bed is in use the manual requires that transport axle to be retracted up under the bed and held in place by a pin with a locking ball on the tip. The pin was found, not in position. The pin must be out for the transport axle and attached casters to rotate. Training issues. This bed was shipped to the original dealer in (b)(6) 2006. There are no reported issues. The original company and inventory was sold to another company. This rental bed was deliver to the facility on (b)(6) 2014 and moved to another room by the dealer on (b)(6). The delivery company indicated the bed was not setup properly in that the transport axles were not retracted for the pt use position per the instruction in the manual. In addition the facility indicated they did not receive the manuals with the bed from this dealer. The dealer indicated they sent manuals with all their beds. We have offered to provide manuals to the dealer and the dealer declined as they have the manuals. We have sent manuals. Conclusions: there is no serious injury. There is no defect in the bed. The dealer indicated they did not follow set up instructions.
Patient Sequence No: 1, Text Type: N, H10
[55574550]
It is alleged: on (b)(6) 2014, a rental bed collapsed while the pt's wife was sitting on the edge of the bed. Pt was not in the bed. The incident was reported the next day to the facility and that the wife was taken to the hospital. It was indicated that the wife had injured her back, left elbow and shoulder and had received medication for discomfort. The transport axle was improperly left down and locking pin not in place. There is no serious injury or bed defect.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1919278-2014-00001 |
| MDR Report Key | 4425900 |
| Date Received | 2014-12-08 |
| Date of Report | 2014-12-08 |
| Date of Event | 2014-10-26 |
| Date Mfgr Received | 2014-11-10 |
| Device Manufacturer Date | 2006-01-01 |
| Date Added to Maude | 2015-01-16 |
| 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 | DUWAYNE KRAMER, JR |
| Manufacturer Street | 1800 MERRIAM LN. |
| Manufacturer City | KANSAS CITY KS 66106 |
| Manufacturer Country | US |
| Manufacturer Postal | 66106 |
| Manufacturer Phone | 9137225658 |
| Manufacturer G1 | BURKE, INC. |
| Manufacturer Street | 1800 MERRIAM LN. |
| Manufacturer City | KANSAS CITY KS 66106 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 66106 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BURKE TRI-FLEX II |
| Generic Name | HOSPITAL BED |
| Product Code | FNJ |
| Date Received | 2014-12-08 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BURKE, INC. |
| Manufacturer Address | 1800 MERRIAM LN. KANSAS CITY KS 66106 US 66106 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-12-08 |