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

Model Number 1105

Device Problem Entrapment of Device (1212)

Patient Problem Physical Entrapment (2327)

Event Date 09/02/2014

Event Type  Other  

Event Description

Hill-rom received a report from the account stating the pt was found with their head stuck inside the side rail.The bed was located in the rehab unit at the account.There was no pt/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

The hill-rom tech found no issues or problems with the bed.He also confirmed that the bed was not fitted with the hbsw side rail gap reducing kit offered by hill-rom.The (b)(6) management stated that the pt involved was 2 months post low level stroke and was immobile.She confirmed the nursing staff had checked on this pt 25 minutes prior to finding him with his head inside the side rail space.The account had to cut the side rail in order to safely free the pts head.The account confirmed that the pt was not injured from this issue.The account did not repair the bed after they cut the side rail due to the fact that they will be acquiring new beds at the facility.This bed was scrapped.

• Brand Name: ADVANCE 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 east; batesville, IN 47006 ; 8129312359
• MDR Report Key: 4187553
• MDR Text Key: 5097579
• Report Number: 1824206-2014-02376
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/02/2014

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: 1105
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/02/2014
• Initial Date FDA Received: 10/02/2014
• 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): Other