MAUDE Adverse Event Report: INVACARE CONTINUING CARE BED, MANUAL; 880.5120

Model Number IHCS7

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Event Description

It was reported by the customer that the leg and link assembly is not working to engage the floor lock.No patient injury alleged, no additional information provided.

• Brand Name: BED, MANUAL
• Type of Device: 880.5120
• Manufacturer (Section D): INVACARE CONTINUING CARE; 994 hargrieve road; london N6E 1P5; CA N6E 1P5
• Manufacturer (Section G): INVACARE CANADA; 570 matheson blvd e; unit 8; mississauga on L4Z 4G4; CA L4Z 4G4
• Manufacturer Contact: karen loughren ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4036990
• MDR Text Key: 4843809
• Report Number: 3003433498-2014-00170
• Device Sequence Number: 1
• Product Code: FNJ
• 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
• Type of Report: Initial
• Report Date: 07/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IHCS7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/28/2014
• 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