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

Model Number 6000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Contusion (1787); Fall (1848); Skin Tears (2516)

Event Date 05/23/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Through investigating the incident it was determined that the device was used by individuals without proper training prior to the event.The chair was likely removed from the rest of the device for cleaning and placed on top of the lower section of the carrier as opposed to interfacing the chair's bearings with the rails properly.Due to this the chair's guards located under the bearings were resting on the rails instead of under them where they would have worked with the bearings to secure the chair in place.The incident occurred as the patient shifted to the side and thus caused the chair to shift and fall between the rails.

Event Description

Patient fell from transfer device chair and suffered contusion requiring stitches.

• 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 ; 540 main street; somerset, WI 54025 ; 7152475625
• MDR Report Key: 6012045
• MDR Text Key: 56913559
• Report Number: 2182947-2016-00001
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nursing Assistant
• Device Model Number: 6000
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2006
• 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
• Patient Outcome(s): Hospitalization