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

Model Number 1900

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 03/19/2015

Event Type  malfunction  

Event Description

Hill-rom received a report from the account stating the left hand cpr leer was loose.The bed was located at he account in room 516.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 found a broken roll pin on cpr lever causing the cpr not to work.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in 2014.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the broken roll pin on cpr lever to resolve the issue.Based on this information, no further action is required.

• Brand Name: TOTALCARE BED
• Type of Device: A/C POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): HILL-ROM, INC.; batesville IN 47006
• Manufacturer Contact: john cummings ; 1069 state route 46 east; batesville, IN 47006 ; 8129312869
• MDR Report Key: 4713851
• MDR Text Key: 20365673
• Report Number: 1824206-2015-00502
• 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: 03/19/2015

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?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/19/2015
• Initial Date FDA Received: 04/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2012
• 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