MAUDE Adverse Event Report: HILL-ROM, INC. CENTURY BED; A/C POWERED ADJUSTABLE HOSP BED

Model Number P837

Device Problem Insufficient Information (3190)

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

Event Date 11/28/2014

Event Type  Death  

Event Description

Hill-rom received a report and request for info from the dept of health and human svs, stating a pt death occurred.The facility filed (b)(4).The resident was found in her room on the floor with her head entrapped between the side rail and the mattress.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

The hill-rom tech inspected the bed and found no malfunction.The tech did note the bed had a non-hill-rom mattress installed and the bed was not equipped with hbsw (b)(4)evaluating the dimensional limits of the gaps in hosp beds is only a component of an overall assessment for entrapment.Therefore, the risk of entrapment is not solely induced by the device but inherent to medical care.Due to no malfunction of the bed and based on this info, no further action is required.

• Brand Name: CENTURY BED
• Type of Device: A/C POWERED ADJUSTABLE HOSP BED
• Manufacturer (Section D): HILL-ROM, INC.; batesville IN
• Manufacturer Contact: tony werner ; 1069 state route 46 e; batesville, IN 47006 ; 8129312359
• MDR Report Key: 4476309
• MDR Text Key: 20121546
• Report Number: 1824206-2015-00144
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: P837
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/05/2015
• Initial Date FDA Received: 01/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death