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

Model Number 6000

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Abrasion (1689); Contusion (1787); Fall (1848)

Event Date 12/21/2018

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.

• 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: 8264892
• MDR Text Key: 133846499
• Report Number: 2182947-2019-00001
• 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: Non-Healthcare Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 01/21/2019

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: 01/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2014
• 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