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

Model Number 1170

Device Problem Device Inoperable (1663)

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

Event Date 03/05/2015

Event Type  malfunction  

Event Description

Hill-rom received a report from the account stating the brake not set alarm was inoperable.The bed was located at the account in 4400.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 the brake not set alarm malfunctioning due to the set switch assembly loose from mount not making contact point.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed.It is unk if the facility performed any other preventative maintenance on this bed.The tech reinstalled and adjusted switch assembly to resolve the issue.Based on this info, no further action is required.

• Brand Name: CAREASSIST BED
• Type of Device: A/C POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): HILLROM DE MEXICO S DE RL DE CV; apodaca ; MX
• Manufacturer Contact: john cummings ; 1069 state route 46 east; batesville, IN 47006 ; 8129312869
• MDR Report Key: 4653204
• MDR Text Key: 5602112
• Report Number: 3006697241-2015-00170
• 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: Unknown
• Type of Report: Initial
• Report Date: 03/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2015
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2009
• 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