MAUDE Adverse Event Report: CARROLL HEALTHCARE CS BED 9153650455; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number CS7

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Material Integrity Problem (2978)

Patient Problem Pressure Sores (2326)

Event Type  malfunction  

Event Description

Facility reported to invacare that the srs2080 glissando mattress on a carroll healthcare cs7 bed is bowing or curling up at the head and foot ends, coming out of the foot end mattress keeper.Resident allegedly sustained a heel pressure ulcer.Invacare visited the facility (included a clinical manager) and when looking at the cs7 bed it was apparent that the foot end of the mattress was not in the correct position.The mattress had come out of the foot end mattress keeper, the sheet appeared to be too small to fit the mattress and was causing the mattress to bend up at the foot section.When articulating the head and foot sections of the bed it became more apparent that the sheet was too small for the mattress.When the sheet was removed from the mattress, the mattress fit in the mattress keeper properly.The facility was using an invacare mattress but the non-invacare covers they put on the mattress was causing the issue.There was no malfunction of the invacare products.Mdr filed based on the sustained injury.User resides in a facility, no mention of medical treatment for the pressure ulcer.

• Brand Name: CS BED 9153650455
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): CARROLL HEALTHCARE; 994 hargrieve rd; london, on N6E 1P5; CA N6E 1P5
• Manufacturer (Section G): CARROLL HEALTHCARE; 994 hargrieve rd; london, on N6E 1P5; CA N6E 1P5
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4711908
• MDR Text Key: 5735519
• Report Number: 3003433498-2015-00057
• 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: Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 03/27/2015

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: CS7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/27/2015
• Initial Date FDA Received: 04/21/2015
• 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