MAUDE Adverse Event Report: APOLLO CORPORATION APOLLO WHIRLPOOL BATH; BATH CHAIR

Model Number	6000
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848); Laceration(s) (1946)
Date of Event	10/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: APOLLO WHIRLPOOL BATH
• Common Device Name: BATH CHAIR
• Manufacturer (Section D): APOLLO CORPORATION; 450 main street; somerset WI 54025
• MDR Report Key: 7026220
• Report Number: 2182947-2017-00003
• Device Sequence Number: 1132219
• Product Code: ILJ
• UDI-Device Identifier: 00866595000203
• UDI-Public: (01)00866595000203(11)161115
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 6000
• Device Catalogue Number: 110024
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/18/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1