MAUDE Adverse Event Report: HILL-ROM HILL-ROM AC POWERED ADJUSTABLE HOSPITAL BED; ELECTRIC HOSPITAL BED

Model Number 837

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

Patient Problems Death (1802); Physical Entrapment (2327); Respiratory Failure (2484); Loss Of Pulse (2562)

Event Date 11/28/2014

Event Type  Death  

Event Description

Reporter called to report adverse event regarding a hill-rom hospital bed.Reporter stated that resident was found on the floor with her head entrapped between the side rail and the mattress at 4:35am on (b)(6) 2014.Reporter stated that she was facing the head of the bed and had no pulse or respiration.Reporter said the resident was last checked on at 2:35am and was fine.Reporter stated there was no noticeable or unusual malfunction of the bed.Reporter said the resident had recently become full-assist, and was unable to help with bed mobility.Reporter stated that on (b)(6) 2014, the resident had lab work done and it was noted that her potassium level was 2.8 and hemoglobin was 7.7.Device available for eval.

• Brand Name: HILL-ROM AC POWERED ADJUSTABLE HOSPITAL BED
• Type of Device: ELECTRIC HOSPITAL BED
• Manufacturer (Section D): HILL-ROM; batesville IN 47006
• MDR Report Key: 4300465
• MDR Text Key: 5084758
• Report Number: MW5039379
• Device Sequence Number: 1
• Product Code: FNL
• 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: 12/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 837
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 84 YR
• Patient Weight: 77