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

Model Number 1900

Device Problems Device Operates Differently Than Expected (2913); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/10/2015

Event Type  malfunction  

Event Description

Hill-rom received a report from a hill-rom technician stating the head section would not lower when cpr lever was used.The bed was located in a patient room 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 found cpr valve rubber stopper had blocked the port.A search of the hill-rom maintenance records did not show hill-rom performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.The tech replaced the cpr valve 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
• Manufacturer Contact: tony werner ; 1069 state rte 46 e; batesville, IN 47006 ; 8129312359
• MDR Report Key: 4689480
• MDR Text Key: 18786010
• Report Number: 1824206-2015-00484
• 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: 03/10/2015

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: 03/10/2015
• Initial Date FDA Received: 04/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2011
• 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