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

Model Number IHCS7

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Death (1802); Asphyxia (1851)

Event Date 06/25/2016

Event Type  Death  

Manufacturer Narrative

Dealer said the bed was checked and put back in service because it was in good working order.There is no alleged malfunction or defect in the bed.Their investigation determined that the patient intentionally crawled under the bed and lowered the entire bed down on top of them causing asphyxiation.The coroner determined it was suicide.Per the invacare cs series beds user manual, "close supervision is necessary when this product is used near or by children or people with disabilities.Do not let any individual underneath the bed or in between the raised bed frame components at any time." the bed frame contains a warning label which states, "crush hazard due to low bed clearance.Stay clear of frame and ensure children and pets are not under or near the frame before lowering the bed.Beware of pinch points below deck panels, next to fixed attachments and between moving parts." should additional information become available, a supplemental record will be filed.

Event Description

Customer alleges the patient purposely lowered the bed on themselves causing asphyxiation.When the patient was found, they had already expired.

• Brand Name: CS BED 9153650455
• 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: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 6059817
• MDR Text Key: 58452178
• Report Number: 3003433498-2016-00261
• 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: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 10/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 10/20/2016
• 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): Death