MAUDE Adverse Event Report: INVACARE CORP. OCEAN VIP SHOWER COMMODE CHAIR; CHAIR, ADJUSTABLE, MECHANICAL

Model Number A1470713

Device Problem Device Tipped Over (2589)

Patient Problem Injury (2348)

Event Date 09/19/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, (b)(6) was being transferred in an aquatic ocean vif shower/ commode chair (sn (b)(4), mgf.Feb.2009) manufactured by invacare when it tipped forward and caused him injury that resulted in hospitalization.The incident occurred when the casters were in the rear position and the patient's body was positioned forward.On 4/23/2014, invacare issued a field safety notice ("fsn") for the product in question in a foreign market.The fsn warns the chair may tip forward under the circumstances that occurred on the date in question and that the hazard can be addressed by affixing after-market antitipper bars.A representative of invacare testified on 10/23/2018 that the fsn applied to the product in question and that invacare did not provide a copy of the fsn or the information contained in that notice to either the fda or any other party in the chain of distribution.Consequently, neither the patient nor providers were aware of the tipping hazard known to the manufacturer.Engineer (b)(4) concluded in a report date 9/20/2018 that the incident would not have occurred had the antitipper bars been affixed to the chair.

• Brand Name: OCEAN VIP SHOWER COMMODE CHAIR
• Type of Device: CHAIR, ADJUSTABLE, MECHANICAL
• Manufacturer (Section D): INVACARE CORP.; elyria OH
• MDR Report Key: 8174813
• MDR Text Key: 131185978
• Report Number: MW5082195
• 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: Other
• Type of Report: Initial
• Report Date: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A1470713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 33 YR
• Patient Weight: 62