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 01/30/2015

Event Type  malfunction  

Event Description

Hill-rom rec'd a report from a hill-rom tech stating the head section would not lower when cpr lever was used.The bed was located in the icu at the account.There was no pt/user injury reported.This report was filed in out complaint handling sys as complaint #(b)(4).

Manufacturer Narrative

Hill-rom tech support suggested checking the cpr valve.Per the hill-rom svc manual the totalcare bed system required an effective maintenance program.We recommend that you preform a semi-annual preventative maintenance.Preventative maintenance will minimize downtime due to excessive wear.Test the cpr release for proper operation and reset of the head cylinder.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance records showed hill-rom performed preventative maintenance on this bed in 2015.It is unk if the facility performed any other preventative maintenance on this bed.No further info is available on the repair of the bed at this time.The investigation is ongoing, however if any add'l relevant info is identified following completion of the investigation, the add'l relevant info 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: tony werner ; 1069 state route 46 e; batesville, IN 47006 ; 8129312359
• MDR Report Key: 4577259
• MDR Text Key: 5486825
• Report Number: 1824206-2015-00290
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2015
• 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: 01/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2006
• 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