MAUDE Adverse Event Report: CARROLL HEALTHCARE BED ENDS G-SERIES BED 9153653717; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number IHECHO

Device Problems Material Integrity Problem (2978); Scratched Material (3020)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Photographs were requested.The dealer declined to provide photographs.No photographs are available for investigation.No return anticipated, as bed was serviced by dealer.Dealer reported that he filed down the sharp edge.Complaint cannot be confirmed.The underlying cause could not be determined after reviewing the documentation in this investigation.Dealer declined to provide additional information citing hipaa.Additional information is not anticipated; however, should additional information become available a supplemental record will be filed.

Event Description

Dealer stated he has an issue with deck pieces on an echo bed, knee section.Dealer stated the knee section on left side of bed has a lip on the side that is very sharp and a resident was injured.Dealer stated it looked like the molding of the deck piece was never filed when it left the factory.Dealer stated that they had a mattress on the bed when the injury occurred.Dealer did not feel comfortable providing any more information in regards to the resident.Dealer stated he filed it down where the lip was sticking out.Dealer stated this is the first injury they have had with the model bed, they have more in the facility.Dealer stated resident did receive stitches and is hospitalized.Dealer did not feel comfortable providing any more information in regards to the resident due to hipaa laws.

• Brand Name: BED ENDS G-SERIES BED 9153653717
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): CARROLL HEALTHCARE; 994 hargrieve rd; london, on N6E 1 P5; CA N6E 1P5
• Manufacturer (Section G): CARROLL HEALTHCARE; 994 hargrieve rd; london, on N6E 1 P5; CA N6E 1P5
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5821707
• MDR Text Key: 50392171
• Report Number: 3003433498-2016-00241
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• 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: 07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IHECHO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/18/2016
• Initial Date FDA Received: 07/26/2016
• 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): Hospitalization