MAUDE Adverse Event Report: HILL-ROM INC. 3 MOTOR ADVANCE BED; AC POWERED ADJUSTABLE HOSPITAL BED

Model Number 1100

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Physical Entrapment (2327)

Event Date 07/29/2014

Event Type  malfunction  

Event Description

The account reported that the pts head was stuck in the side rail of the bed.The bed was located in room 526 but has been taken to the bed repair shop.There was no pt/user injury reported.(b)(4).

Manufacturer Narrative

Hill-rom technician investigated and found that both head and foot side rails did not have side rail inserts to bring it up to the (b)(4) standard.The account was received pricing for the parts and will be installing the inserts when they are ordered and received to resolve the issue.No further information is available on the repair of the bed at this time.If any additional relevant information is identified following completion of the repair, the additional relevant information will be submitted in a supplemental report.

• Brand Name: 3 MOTOR ADVANCE BED
• Type of Device: AC POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): HILL-ROM INC.; batesville IN
• Manufacturer Contact: jennifer morris ; 1069 state rt 46 east; batesville, IN 47006 ; 8129313121
• MDR Report Key: 4041848
• MDR Text Key: 19805487
• Report Number: 1824206-2014-02071
• 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: Health Professional,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 1100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1