MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS BED ENDS G-SERIES BED 9153653717; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number G5510

Device Problems Electrical /Electronic Property Problem (1198); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Shock (2072)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The dealer stated that the end user alleged that when they would touch the rails on the bed they would get a shock.The dealer went out to check the bed and determined that it was a voltage bleed over that was causing the bed give a slight electrical shock of the bed.The dealer already replaced the foot section with another foot section that he had in inventory which caused the problem to stop.

Manufacturer Narrative

Additional/updated information was added to reflect the device receiving an expanded evaluation.However, subsequent testing could not verify the complaint.The foot section and all motors were visually inspected to be in good condition.The cables and cable connectors were visually inspected and were found to be free from cuts, breaks, bends or other damage.The power supply and hand pendant were not returned, so a set of test components was used to assess the functionality of the foot section.All motors functioned correctly, and the foot section was able to raise and lower as intended.No sparks were observed, and no shock was detected when the frame, motors, and cables were physically touched.A multimeter was used to measure the resistance of each motor, which all displayed an open circuit, meaning that no short circuits were found.The underlying cause of the complaint issue could not be determined.

Event Description

The dealer stated that the end user alleged that when they would touch the rails on the bed they would get a shock.The dealer went out to check the bed and determined that it was a voltage bleed over that was causing the bed give a slight electrical shock of the bed.The dealer already replaced the foot section with another foot section that he had in inventory which caused the problem to stop.

• Brand Name: BED ENDS G-SERIES BED 9153653717
• 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: 5267341
• MDR Text Key: 32884707
• Report Number: 1031452-2015-16952
• 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: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 12/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2015
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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