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

Model Number 1900

Device Problem Sticking (1597)

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

Event Date 04/09/2015

Event Type  malfunction  

Event Description

Hill-rom received a report from the account stating the emergency cpr lever did not lower the head section.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 technician support suggested checking the adjustment on cpr linkage and the cpr valve.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in 2013 and 2014.It is unknown if the facility performed any other preventative maintenance on this bed.No further information is available on the repair of the bed at this time.The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.

• Brand Name: TOTALCARE BED
• Type of Device: A/C POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): HILL-ROM, INC.; batesville IN
• Manufacturer Contact: john cummings ; 1069 state route 46 east; batesville, IN 47006 ; 8129312869
• MDR Report Key: 4759889
• MDR Text Key: 20810638
• Report Number: 1824206-2015-00568
• 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: 04/09/2015

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: 1900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/09/2015
• Initial Date FDA Received: 05/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2010
• 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