MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-04-07 for REXX QD2000 manufactured by M. C. Healthcare Products (a Division Of Span Medical Products).
[4550615]
A resident was sitting on the side of her bed. A garbage can had been placed in the close proximity of the bed for the residents use, which was under the bed's edge at the time of bed lowering. The garbage can was located between the pivot point of the head deck and head end of the bed. The resident simultaneously lowered the bed and raised the head deck of the bed. The bed was lowered onto the garbage can and the resident noticed the bed was not lowering properly but continued to lower. The bed was kept from lowering properly at the head end by the garbage can. While the resident was sitting and lowering the bed, her legs were tucked in under the bed. The garbage can suddenly popped out from under the bed, the bed dropped and her calf was partially sheared off her leg. The resident had surgery and is recovering.
Patient Sequence No: 1, Text Type: D, B5
[11768092]
After a review of our post production risk mgmt, this is the first incident of this nature and considered isolated with a likelihood of occurrence being improbable. Our risk analysis was reviewed and proper warnings are covered in the owner's manual. No corrective action(s) required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1041130-2014-00001 |
| MDR Report Key | 3763385 |
| Report Source | 05,06 |
| Date Received | 2014-04-07 |
| Date of Report | 2014-04-07 |
| Date of Event | 2014-03-12 |
| Date Mfgr Received | 2014-03-13 |
| Date Added to Maude | 2014-04-25 |
| 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 | 4658 ONTARIO ST |
| Manufacturer City | BEAMSVILLE L0R 1B4 |
| Manufacturer Country | CA |
| Manufacturer Postal | L0R 1B4 |
| Manufacturer Phone | 8646786936 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REXX |
| Generic Name | QD2000 |
| Product Code | BRT |
| Date Received | 2014-04-07 |
| Model Number | QD2000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | M. C. HEALTHCARE PRODUCTS (A DIVISION OF SPAN MEDICAL PRODUCTS) |
| Manufacturer Address | 4658 ONTARIO ST BEAMSVILLE L0R1B4 CA L0R 1B4 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-04-07 |