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

Model Number HCBED

Device Problems Mechanical Problem (1384); Noise, Audible (3273)

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

Event Date 11/03/2014

Event Type  malfunction  

Event Description

As a result of pin holding power head actuator mechanism breaking or popping out, end user allegedly dropped into a horizontal position while raising head of bed.He apparently had some initial pain and saw doctor.There was no rehab or medication prescribed.End users issue at this point is noise that bed makes when he initiates raising head of bed.He also claims that there has been oil and metal shavings left on carpet under bed.Dealer technician replaced original pin for actuator with a stronger more robust bolt and also replaced headboard guide wheels with superior urethane ones to help eliminate noise.Dealer technician says he cannot fid source of leaking oil or metal shavings.Dealer technician claims that reason bed is making a noise, is a result of end user's weight being close to or over the maximum weight capacity of bed when adding weight of the side rails and mattress.Dealer technician also claims that bed makes no noise when lifting his own personal weight.((b)(6)).

Manufacturer Narrative

A follow up will be sent if the product or additional information is obtained.

• Brand Name: CS BED 9153650455
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): INVACARE CONTINUING CARE; 994 hargrieve road; london N6E 1P5; CA N6E 1P5
• Manufacturer (Section G): INVACARE CONTINUING CARE; 994 hargrieve road; london N6E 1P5; CA N6E 1P5
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4817471
• MDR Text Key: 18628751
• Report Number: 3003433498-2015-00075
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 05/07/2015

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: HCBED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/07/2015
• Initial Date FDA Received: 06/04/2015
• 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
• Patient Age: 61