MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS 68 IN PARTIAL RAIL 9153650594; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number G5510

Device Problems Sticking (1597); Device Stops Intermittently (1599); Sparking (2595)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

End user is stating when the bed pendant is used, the bed is not moving at all.End user states this is intermittent, that the bed has worked at times.End user further states when the plug is plugged into the wall, there is sparking.End user is unsure if its the outlet or the plug that is sparking, but thinks it is the plug.End user stated that she has had this bed since (b)(6) 2014, and is just now using it.Referred back to the va for service.No other information provided.

Manufacturer Narrative

Should additional information become available, a supplemental record will be filed.

• Brand Name: 68 IN PARTIAL RAIL 9153650594
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): INVACARE FLORIDA OPERATIONS; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer (Section G): INVACARE FLORIDA OPERATIONS; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4919791
• MDR Text Key: 15235835
• Report Number: 1031452-2015-14894
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/22/2015

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: G5510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/22/2015
• Initial Date FDA Received: 07/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other