MAUDE Adverse Event Report: HILL-ROM, INC. TOTALCARE BEDS; A/C POWERED ADJUSTABLE HOSPITAL BED

Model Number 1900

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/30/2015

Event Type  malfunction  

Event Description

Hill-rom received a report from the account stating the cpr function was inoperable.The bed was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

The hill-rom tech found the hydraulic manifold inoperable.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in 2013 and 2015.It is unknown if the facility performed any other preventative maintenance on this bed.The tech replaced the hydraulic manifold to resolve the issue.Based on this information, no further action is required.

• Brand Name: TOTALCARE BEDS
• Type of Device: A/C POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): HILL-ROM, INC.; batesville IN
• Manufacturer Contact: john cummings ; 1069 state rte 46 e; batesville, IN 47006 ; 8129312869
• MDR Report Key: 4737426
• MDR Text Key: 5884485
• Report Number: 1824206-2015-00536
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122473
• 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: 03/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 1900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2006
• 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