MAUDE Adverse Event Report: GOODBABY 3 POSITION RECLINER DLX-X WIDE BLUE RIDGE 9153641314; CHAIR AND TABLE, MEDICAL

Model Number IH6065WD/IH61

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The caller states that the ratchet has broken on the chair.(b)(4) was previous complaint for the same part breaking.Dealer states, his patient states that something is bent in the back of the chair where the push handle attaches to the chair.

• Brand Name: 3 POSITION RECLINER DLX-X WIDE BLUE RIDGE 9153641314
• Type of Device: CHAIR AND TABLE, MEDICAL
• Manufacturer (Section D): GOODBABY; CH
• MDR Report Key: 4429262
• MDR Text Key: 5283906
• Report Number: 1531186-2015-00349
• 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: 01/16/2015,01/07/2015

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: Lay User/Patient
• Device Model Number: IH6065WD/IH61
• 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: 01/16/2015
• Distributor Facility Aware Date: 01/07/2015
• Device Age: 2 YR
• Date Report to Manufacturer: 01/16/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/16/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other