MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS CS BED 9153650455; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number G5510

Device Problems Device Inoperable (1663); Sparking (2595)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Sparks were seen coming from the foot section of the bed and then bed had no function at all.

Manufacturer Narrative

Additional/updated information was added to reflect the device being returned to the manufacturer for evaluation, however subsequent testing could not verify the complaint, and the underlying cause of the complaint issue could not be determined.Per the expanded evaluation report, no sparks were observed coming from any of the electronic components on the foot section during bed operation.Both the head and foot actuators operated properly when tested.However, the hi-lo actuator could not be operated using the returned hand pendant due to a broken/missing connector pin.

Event Description

Sparks were seen coming from the foot section of the bed and then bed had no function at all.

• Brand Name: CS BED 9153650455
• 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: 5833480
• MDR Text Key: 51162807
• Report Number: 1031452-2016-03139
• 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: 08/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2016
• 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: 08/31/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2016
• 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