MAUDE Adverse Event Report: HILLROM DE MEXICO S DE RL DE CV CAREASSIST BED; A/C POWERED ADJUSTABLE HOSPTIAL BED

Model Number 1170

Device Problem Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/19/2014

Event Type  malfunction  

Event Description

The account reported the head section will not stay in the raised position.The bed was located in the bed repair area at the facility.There was no pt/user injury reported.(b)(4).

Manufacturer Narrative

The account found the head of the bed will lower if cpr lever is pulled but then they have to manually raise the head section.The account ordered a replacement head drive and plugged it into the motor control board and the motor started to operate unintentionally.Hill-rom technical support supplied the account with the part number for a motor control board.No further info is available on the repair of the bed at this time.The investigation is ongoing, however if any additional relevant info is identified following completion of the investigation, the additional relevant info will be submitted in a supplemental report.

• Brand Name: CAREASSIST BED
• Type of Device: A/C POWERED ADJUSTABLE HOSPTIAL BED
• Manufacturer (Section D): HILLROM DE MEXICO S DE RL DE CV; apodaca ; MX
• Manufacturer Contact: jennifer morris ; 1069 state route 46 east; batesville, IN 47006 ; 8129313121
• MDR Report Key: 3937598
• MDR Text Key: 4601793
• Report Number: 3006697241-2014-00356
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 1170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/19/2014
• Initial Date FDA Received: 04/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2013
• 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