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

Model Number 6000

Device Problems Material Separation (1562); Device Fell (4014)

Patient Problems Fall (1848); Injury (2348)

Event Date 07/30/2019

Event Type  malfunction  

Manufacturer Narrative

Through evaluating the accounts of those involved in the incident, inspecting the device in question, and attempting to reproduce the incident, it was determined that incident was not caused by a failure of the device.Once inspection of the device was completed, it was verified that both the primary and secondary locks were functioning correctly and that the failure could not be reproduced.With this being the case it is likely that the resident was not all the way onto the base of the carrier prior to the carrier being released from the tub.The account from the attendant indicates that they were confident that they had pulled the chair all the way forward; however, they verified this immediately after the chair was moved out of the tub.As such, it's possible that the resident could have released the primary lock while the attendant was in the process of drying and dressing them.If the resident released the chair and slid back without the attendant noticing, it would enable such an event to occur.The facility did report that this particular resident is inclined to fumbling with and disassembling things around the facility, which makes this explanation feasible.In order to prevent such an event from reoccurring apollo instructed the staff to always do a final push/ pull check on the chair before releasing it from the tub as to verify that the primary lock is engaged.Apollo also conducted additional training for the facility and inspected all of their bathing systems to ensure that everything was in working order.

Event Description

Prior to the event occurring, the attendant had moved the chair out of the tub and onto the docked carrier base.After this the attendant proceeded to dry off the resident and get them dressed at which point they noticed that there was some water under their feet.As to avoid getting the residents socks wet, the attendant released the carrier from the tub and attempted to move it to a dryer location.Upon moving the carrier away from the tub, the chair separated from the base and fell between the base and the tub causing the resident to fall and hit their head on the front of the tub.The resident was evaluated at the er and was found to have no significant injuries and was thus returned to the facility.

• Brand Name: APOLLO WHIRLPOOL BATH
• Type of Device: BATH CHAIR
• Manufacturer (Section D): APOLLO CORPORATION; 450 main street; somerset WI 54025
• Manufacturer Contact: randall dekan ; 450 main street; somerset, WI 54025 ; 7152475625
• MDR Report Key: 8952076
• MDR Text Key: 198029451
• Report Number: 2182947-2019-00002
• Device Sequence Number: 1
• Product Code: ILJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 08/28/2019

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
• Device Operator: Health Professional
• Device Model Number: 6000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1