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

Model Number 6000

Device Problem Device Tipped Over (2589)

Patient Problem Injury (2348)

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

After discussions with staff and inspection of transfer system, it was determined that the chair was not fully transferred onto the scale base when the transfer system was disengaged from the tub (operator error).As the chair was moved away from the tub the rear wheels of the chair were not on the carrier rails, allowing the chair to tip backwards off of the base.This is supported by the fact that the front chair tabs were bent downward.The small size of the bathing room likely played a part in the incident, as there is very little room in front of the tub.This requires the transfer to be done entirely from the side of the tub, making it difficult to determine if the chair is fully transferred and difficult to move the resident in general.In addition to this, the unit was missing the alignment decal used to visually indicate that the chair is pulled all the way onto the base.Apollo demonstrated the proper protocol for transferring residents into and out of the tub.The other two apollo bathing systems were inspected for proper operation and adjustment while our representative was there.They appeared to be in good working order, although both of the other tubs were missing the red transfer indicator caps on the rails of the carrier (newer models).None of the 3 tubs were secured to the floor, so we discussed how to secure them with maintenance and the administrator.We also discussed the importance of preventative maintenance and inspections of the equipment.Copies of the appropriate transfer instruction reference sheets were sent to the facility to be hung in the bathing rooms.Apollo also sent replacement red indicator caps for the newer systems and alignment stickers for the older unit.

Event Description

The cna had completed the bath and transferred the resident out of the tub onto the scale base.After undocking the transfer system from the tub and beginning to move the resident away from tub, the chair and resident tipped backwards off of the lower carrier.The cna was able to catch the resident and lower them to the floor.The resident was not injured, but the cna injured her shoulder in the process.

• Brand Name: APOLLO WIRLPOOL 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: 9519890
• MDR Text Key: 219767878
• Report Number: 2182947-2019-00003
• 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: Other
• Type of Report: Initial
• Report Date: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• 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
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2007
• 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