MAUDE Adverse Event Report: HOSPITAL BED

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.

• Brand Name: HOSPITAL BED
• Type of Device: BED
• MDR Report Key: 6249039
• MDR Text Key: 64901126
• Report Number: MW5067192
• Device Sequence Number: 1
• Product Code: FNJ
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 01/12/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 88 YR
• Patient Weight: 60