MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-05 for ADVANTA P1600 manufactured by Hill-rom.
[75524559]
After pt returned from ambulating to the restroom, he leaned on his hospital bed to get back into bed. The bed then slid back, and he fell to the floor on his left side, sustaining an abrasion on his left elbow. The next day, he was unable to bear weight on his left leg, and imaging tests indicated an acute fracture to his left hip. Surgical intervention not recommended at this time. Referred to a rehab facility for initial pt. (b)(4) inspected suspected device. During testing, brakes were locked with casters adjusted in various positions, then a significant amount of pressure was applied to several locations on the bed's weigh frame side (head, intermediate, and foot sections) while in the high-low-high and low-high and low positions. Simulated a patient entering and exiting the bed with the bed in the lowest position and brakes in the lock position. It was concluded that when the brake function was engaged, the brakes worked as designed. No defects were found from the reported complaint, and no repairs were required nor recommended.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6576678 |
| MDR Report Key | 6576678 |
| Date Received | 2017-05-05 |
| Date of Report | 2017-04-28 |
| Date of Event | 2017-04-14 |
| Date Facility Aware | 2017-04-14 |
| Report Date | 2017-04-28 |
| Date Reported to FDA | 2017-04-28 |
| Date Reported to Mfgr | 2017-04-28 |
| Date Added to Maude | 2017-05-18 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ADVANTA |
| Generic Name | ELECTRIC HOSPITAL BED |
| Product Code | FNJ |
| Date Received | 2017-05-05 |
| Model Number | P1600 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 15 YR |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILL-ROM |
| Manufacturer Address | BATESVILLE IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-05-05 |