MAUDE Adverse Event Report: HILL-ROM MEXICO ADVANTA 2 FRAME; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number P1190A000044

Device Problem Defective Alarm (1014)

Patient Problem No Patient Involvement (2645)

Event Date 11/13/2018

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician found the brake switch cam was not connected.Per the hill-rom service manual, the bed should be subject to an effective maintenance program.An annual service of the bed is advised in order to maintain its characteristics and performance.Brake alarm system: connect the bed to a wall power source, and set the brake to neutral.Make sure that the alarm activates and that you can hear it.If you cannot hear the alarm, troubleshoot the alarm and replace parts as necessary.Make sure that the alarm deactivates when the brake is set while the bed is connected to a wall power source.Make sure that the brake alarm switch is in the correct position.Adjust or replace parts as necessary.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 technician reconnected the brake switch cam to resolve the issue.Based on this information, no further action is required.

Event Description

Hill-rom received a report from a hill-rom technician stating the bed's brake not set alarm was not working.The bed was located in the hallway at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: ADVANTA 2 FRAME
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): HILL-ROM MEXICO; ave.del telefono no. 200 col. huinala; apodaca, nuevo leon 66640 ; MX 66640
• Manufacturer Contact: lori daulton ; 1069 state route 46 east; batesville, IN 47006 ; 8129312280
• MDR Report Key: 8115784
• MDR Text Key: 128902227
• Report Number: 3006697241-2018-00105
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/13/2018

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: No Information
• Device Model Number: P1190A000044
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/13/2018
• Initial Date FDA Received: 11/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1