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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOSPITAL BED

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HOSPITAL BED Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Abrasion (1689); Death (1802); Asphyxia (1851)
Event Date 12/20/2016
Event Type  Death  
Event Description
Patient was in his resident, around 9am wife found him between mattress and railing of hospital bed unresponsive. Wife called caretaker for help. Caretaker performed cpr while wife called 911; 911 arrived and continued performing cpr but could not resuscitate patient. Patient was pronounced dead at 9:40am. Law enforcement called investigational officer who then came to the deceased residence. Investigational officer saw red abrasion on the deceased neck. The deceased pt was then transferred to the medical examiner office. An autopsy was done and it was ruled pt died of positional asphyxia due to head and neck been compressed between metal railing and mattress of the hospital bed.
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Type of DeviceBED
MDR Report Key6249039
MDR Text Key64901126
Report NumberMW5067192
Device Sequence Number1
Product Code FNJ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2017
Is this an Adverse Event Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/12/2017 Patient Sequence Number: 1