MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-11-13 for APOLLO WHIRLPOOL BATH 6000 110024 manufactured by Apollo Corporation.
[91897343]
An apollo representative was sent on site to investigate the incident and provide additional training to facility staff. Through inspection and testing of the device, it was found that the device and all of its safety mechanisms were functioning correctly. Although the incident couldn't be reproduced under proper usage conditions, it was found that the event could be reproduced if the chair (upper transfer device) was not pulled completely forward and into the locking mechanism as per the instruction sheet, operating manual, and device warning sticker. This would indicate that the event resulted from the chair not being pulled all the way onto the carrier (lower transfer device) preventing the locking mechanism from engaging. This left the rear wheels of the chair in the tub, while the front wheels were on the carrier. When the transfer system was released from the bathing system and moved away, the rear wheels of the chair dropped between the carrier and the bath tub, resulting in the incident. In addition, it was found that the safety straps were not used at the time of the incident. It was determined that the most appropriate means of preventing a similar incident from occurring again in the future was to conduct additional training with the facility staff. Staff were reminded to ensure the chair is secure before the device is released from the tub. This training was conducted by the apollo representative sent to the facility. Additionally, the facility requested a copy of the transfer instruction sheet that was broken down a bit more to aid in training and referencing. Apollo decided to accommodate this request and take it as an opportunity to improve the document.
Patient Sequence No: 1, Text Type: N, H10
[91897344]
The incident occurred as the caretaker was removing the resident from the bathing system. The caretaker rolled the chair (upper transfer device), with the resident, out of the tub and onto the carrier (lower transfer device. ) at this point the caretaker released the transfer device from the tub. When the transfer device was pulled away from the bathing system, the chair separated from the carrier and the resident and chair fell to the ground. The resident was not secured into the chair with safety straps, but they remained in it throughout the fall. They were taken to the er where they were treated for a laceration on the head that didn't require stitches. The resident had some bruising, but was able to return to (b)(6) extended care.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182947-2017-00003 |
| MDR Report Key | 7026220 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-11-13 |
| Date of Report | 2017-11-09 |
| Date of Event | 2017-10-18 |
| Date Facility Aware | 2017-10-18 |
| Device Manufacturer Date | 2016-11-15 |
| Date Added to Maude | 2017-11-13 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APOLLO WHIRLPOOL BATH |
| Generic Name | BATH CHAIR |
| Product Code | ILJ |
| Date Received | 2017-11-13 |
| Model Number | 6000 |
| Catalog Number | 110024 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-11-13 |