MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-16 for EZ-WIDER BARIATRIC BED ASM100104 manufactured by Kreg Medical Inc.
[102716581]
Report is late due to the firm's technical problem which has recently been resolved. A capa was initiated to correct technical problem, original submission provided an acknowledgement receipt. Discovery of the technical issue was found during the firm's recent inspection by fda on 01/23/2018. Kreg medical has worked with cdrh and esg gateway help desk to resolved issue along with initiating a capa #(b)(4) to prevent reoccurrence.
Patient Sequence No: 1, Text Type: N, H10
[102716582]
Report: kreg received a report on (b)(6) 2015 that the casters on one side of an ez wider bariatric bed rose off the floor while one nurse and one care partner turned a patient laterally in order to perform a bedpan procedure. The brakes were reportedly engaged during this incident with the bed height positioned to the waist level of the nurse. It was reported that both side rails on the side the patient was turning to were in the full up position during this event. The patient was reportedly positioned on her side, against the side rails with a portion of her body hanging outside of the bed perimeter. A wooden arm rest of a bariatric chair in the room was damaged during this incident. The patient restraint holder on the bottom of the foot deck and the patient drainage bag holder under the seat deck were damaged. The damaged restraint holder and drainage bag holder were located on the patient left side of the bed. The opposite side of the bed that the patient was turning to. The patient was also reported to be positioned low in the bed (toward the foot end of the patient platform) when this event took place. The patient weighed (b)(6) and was not injured. Initially one injury to the care partner was reported. He was sent for an mri but did not required hospitalization.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005179379-2016-00003 |
| MDR Report Key | 7347094 |
| Date Received | 2018-03-16 |
| Date of Report | 2015-01-25 |
| Date of Event | 2015-12-27 |
| Date Mfgr Received | 2015-12-27 |
| Device Manufacturer Date | 2015-06-01 |
| Date Added to Maude | 2018-03-16 |
| 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 | MR CRAIG POULOS |
| Manufacturer Street | 1940 JANICE AVE |
| Manufacturer City | MELROSE PARK IL 60160 |
| Manufacturer Country | US |
| Manufacturer Postal | 60160 |
| Manufacturer Phone | 3128298904 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 3005179379-2016-00003 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EZ-WIDER BARIATRIC BED |
| Generic Name | EZ-WIDER BARIATRIC BED |
| Product Code | OSI |
| Date Received | 2018-03-16 |
| Returned To Mfg | 2016-01-21 |
| Model Number | ASM100104 |
| Lot Number | 17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KREG MEDICAL INC |
| Manufacturer Address | 1940 JANICE AVE MELROSE PARK IL 60160 US 60160 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-03-16 |