OCEAN VIP SHOWER COMMODE CHAIR A1470713

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-17 for OCEAN VIP SHOWER COMMODE CHAIR A1470713 manufactured by Invacare Corp..

Event Text Entries

[131185978] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5082195
• MDR Report Key: 8174813
• Date Received: 2018-12-17
• Date of Report: 2018-12-06
• Date of Event: 2015-09-19
• Date Added to Maude: 2018-12-18
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: OCEAN VIP SHOWER COMMODE CHAIR
• Generic Name: CHAIR, ADJUSTABLE, MECHANICAL
• Product Code: INN
• Date Received: 2018-12-17
• Model Number: A1470713
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: INVACARE CORP.
• Manufacturer Address: ELYRIA OH US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Other	2018-12-17