MAUDE Adverse Event Report: INVACARE CONTINUING CARE AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS; 880.5100

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Asphyxia (1851); Physical Entrapment (2327)

Event Date 06/01/2013

Event Type  Death  

Event Description

U.S consumer product safety commission reported that (b)(6) year old female hospice patient, placed in a nursing home, was found by the nursing home staff dead in her cs3 carroll healthcare bed.Her legs were out of the bed, on the floor, her upper body was still on the bed, her left arm was found through the beds' side rail and her head was between the mattress and the side rail.Attempts were made to resuscitate but were unsuccessful, she reportedly died of asphyxiation.According to the report, the facility was unable to determine which of its beds was involved in the incident.The nursing home administrator claimed the mattress involved was an alternating air mattress that was provided by hospice to the patient.This mattress was returned to hospice following the incident.

• Brand Name: AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
• Type of Device: 880.5100
• 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: karen loughren ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4239771
• MDR Text Key: 5060700
• Report Number: 3003433498-2014-00240
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/06/2014
• 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
• Patient Age: 90