MAUDE Adverse Event Report: GOODBABY 3 POSITION RECLINER DELUXE-ADULT ROSEWOOD 9153641333; CHAIR AND TABLE, MEDICAL

Model Number IH6065A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The provider states both of the rear locking wheels on this chair are broken as well as the locking positioning bar.No additional information available per facility rep 7857hf.

• Brand Name: 3 POSITION RECLINER DELUXE-ADULT ROSEWOOD 9153641333
• Type of Device: CHAIR AND TABLE, MEDICAL
• Manufacturer (Section D): GOODBABY; CH
• MDR Report Key: 4395251
• MDR Text Key: 18036867
• Report Number: 1531186-2015-00038
• Device Sequence Number: 1
• Product Code: KMN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Invalid Data
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 01/05/2015,12/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IH6065A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/05/2015
• Distributor Facility Aware Date: 12/12/2014
• Device Age: 22 MO
• Date Report to Manufacturer: 01/05/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other