MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS CS3 BED 9153651161; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number VC5310

Device Problems Unintended System Motion (1430); Device Stops Intermittently (1599); Noise, Audible (3273)

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

Dealer states, the motor is loud and intermittently does not raise the head section of the bed.Sometimes the head section drops down, no injury reported.

Manufacturer Narrative

Product was returned for evaluation.The return fields in oracle state: beds, mattresses, rails.Junction box, not able to duplicate issue.No problem found not set up to test underload.Complaint was not confirmed.The underlying cause could not be determined after reviewing the documentation in this investigation.

Event Description

Product was returned for evaluation.The return fields in oracle state: beds, mattresses, rails.Junction box, not able to duplicate issue.No problem found not set up to test underload.Dealer states the motor is loud and intermittently does not raise the head section of the bed.Sometimes the head section drops down, no injury reported.

• Brand Name: CS3 BED 9153651161
• 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: 5178170
• MDR Text Key: 29869065
• Report Number: 1031452-2015-16461
• 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: 12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: VC5310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/17/2015
• 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