MAUDE Adverse Event Report: APOLLO CORP. BATH, HYDRO-MASSAGE

Model Number WP6000REM

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Skin Tears (2516)

Event Date 03/09/2017

Event Type  malfunction  

Event Description

Safety latch on apollo bathing system failed causing resident to be lowered to the floor.Resident sustained minor injury of two small skin tears.Manufacturer representative witnessed latch failure on recreating incident.Latch was replaced with newer model.Concern is that older style apollo bathing systems may fail causing potential injury or death to a patient or resident.

• Brand Name: BATH, HYDRO-MASSAGE
• Type of Device: BATH, HYDRO-MASSAGE
• Manufacturer (Section D): APOLLO CORP.; somerset WI
• MDR Report Key: 6475426
• MDR Text Key: 72410278
• Report Number: MW5068984
• Device Sequence Number: 1
• Product Code: ILJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WP6000REM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/06/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Weight: 97