MAUDE Adverse Event Report: AQUATEC GMBH AQUATEC ERGO VIP SHOWER CHAIR; CHAIR, ADJUSTABLE, MECHANICAL

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problems Fall (1848); Head Injury (1879)

Event Date 07/16/2020

Event Type  Injury  

Event Description

Product: aquatec ergo dual vip shower chair by (b)(6), and purchased last year through (b)(6) in (b)(6).This is a very expensive (>$2000) shower chair for disabled persons.My son is a (b)(6) old male quadriplegic.During a shower, the back of the shower chair completely broke off from the frame, and my quadriplegic son fell backwards onto our shower floor and sustained a closed head injury.Upon inspection, the shower chair back is/was attached to the seat frame by plastic fittings on each side.The plastic fittings on both sides snapped and the chair back became instantly and totally unattached.My son's male caregiver was present, but could not stop or brace the backwards fall.Two of us were able to pick up my son and carry him to his hospital bed.I am a physician and managed my son as a typical closed head injury.He is doing very well.The chair was being used in a normal fashion and as intended.I am not a reviewer, but i would characterize this product as critically unsafe and potentially life-threatening.(b)(6).Fda safety report id #: (b)(4).

• Brand Name: AQUATEC ERGO VIP SHOWER CHAIR
• Type of Device: CHAIR, ADJUSTABLE, MECHANICAL
• Manufacturer (Section D): AQUATEC GMBH
• MDR Report Key: 10301820
• MDR Text Key: 199916176
• Report Number: MW5095632
• Device Sequence Number: 1
• Product Code: INN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention; Disability
• Patient Age: 30 YR
• Patient Weight: 71