MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS BED EXTENDER 9153650579; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number IHSC900DLX

Device Problems Overheating of Device (1437); Scratched Material (3020)

Patient Problem Injury (2348)

Event Type  malfunction  

Manufacturer Narrative

Should additional information become available a supplemental record will be filed.Reference report number 1031452-2016-01663 for serious injury previously reported.

Event Description

The dealer originally contacted us regarding a serious injury alleged, and after further inspection of an audit across all of their homes, they noticed that this edge was on all of the beds was ranging from a little roughness on the edge to a razor sharp corner.They had to have their maintenance directors go around and file each one down to avoid any future incidents.

Manufacturer Narrative

(b)(4) created for this event.(b)(4) created to resolve issue.No immediate risk noted with event to escalate to capa/crt.One serious injury noted out of all (b)(4) bed throughout a single business unit.Complaint data over a 2 year period did not show any similar issues or injuries with the ihsc900dlx bed.Conclusions of erb show that the underlying cause appears to be metal burs left after molding.Reference report number 1031452-2016-01663 for serious injury previously reported.

Event Description

The dealer originally contacted us regarding a serious injury alleged, and after further inspection of an audit across all of their homes, they noticed that this edge was on all of the beds was ranging from a little roughness on the edge to a razor sharp corner.They had to have their maintenance directors go around and file each one down to avoid any future incidents.

• Brand Name: BED EXTENDER 9153650579
• 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: 5604315
• MDR Text Key: 44223096
• Report Number: 1031452-2016-01783
• 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: other,user facility
• Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup
• Report Date: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IHSC900DLX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2016
• 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