MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-21 for APOLLO WHIRLPOOL BATH 6000 manufactured by Apollo Corporation.
[133846499]
Through inspecting the device it was determined that the incident was caused by the carrier base being out of adjustment. The pin retainer dropped down below its recommended height, preventing the unit from latching properly. It was noted that the docking pin retainer, one load cell, and 3 of the casters were all loose on the unit. The loosening of the pin retainer is likely what led to it falling out of adjustment. All components were tightened and brought back into adjustment by an apollo representative. The representative discussed planned maintenance requirements with the facility's maintenance and administration personnel to prevent reoccurrence of this event.
Patient Sequence No: 1, Text Type: N, H10
[133846500]
Bath aide was preparing to give resident a bath. As the resident was being transferred into tub, the scale base separated from the bath tub and the resident and chair fell between the scale base and the tub. The resident hit their head on side of tub during the fall, causing a contusion and 3 small abrasions on head.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182947-2019-00001 |
| MDR Report Key | 8264892 |
| Date Received | 2019-01-21 |
| Date of Report | 2019-01-21 |
| Date of Event | 2018-12-21 |
| Device Manufacturer Date | 2014-05-19 |
| Date Added to Maude | 2019-01-21 |
| 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. RANDALL DEKAN |
| Manufacturer Street | 450 MAIN STREET |
| Manufacturer City | SOMERSET WI 54025 |
| Manufacturer Country | US |
| Manufacturer Postal | 54025 |
| Manufacturer Phone | 7152475625 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | APOLLO WHIRLPOOL BATH |
| Generic Name | BATH CHAIR |
| Product Code | ILJ |
| Date Received | 2019-01-21 |
| Model Number | 6000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APOLLO CORPORATION |
| Manufacturer Address | 450 MAIN STREET SOMERSET WI 54025 US 54025 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-21 |