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

Model Number 1900

Device Problem Sticking (1597)

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

Event Date 10/16/2014

Event Type  malfunction  

Event Description

Hill-rom received a report from the account stating the head section would not lower when cpr lever was used.The bed was located in engineering at the account.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 technician found the cpr valve was stuck in the manifold.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in 2013 and 2014.It is unk if the facility performed any other preventative maintenance on this bed.The tech replaced the cpr valve to resolve the issue.Based on this info, no further action is required.

• Brand Name: TOTALCARE BED
• Type of Device: A/C POWERED ADJUSTABLE HOSP BED
• Manufacturer (Section D): HILL-ROM, INC.; batesville IN
• Manufacturer Contact: tony werner ; 1069 state route 46 e; batesville, IN 47006 ; 8129312359
• MDR Report Key: 4259300
• MDR Text Key: 5049875
• Report Number: 1824206-2014-02614
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962942
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 10/16/2014

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: 1900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/16/2014
• Initial Date FDA Received: 11/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2005
• 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