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

Model Number P1190A000055

Device Problem Self-Activation or Keying (1557)

Patient Problem No Patient Involvement (2645)

Event Date 11/13/2018

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician found the right and left siderail caregiver controls needed to be replaced.Per the hill-rom service manual the advanta¿ 2 should be subject to an effective maintenance program.This will help make sure of a long, operative life for the advanta¿ 2 bed.The preventative maintenance will help to reduce downtime due to excessive wear failures.An annual service of the bed is advised in order to maintain its characteristics and performance.Make sure all functions on the caregiver controls operate correctly.Repair or replace the side rail as necessary.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in (b)(6) 2018.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the right and left siderail caregiver controls 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 head of the bed was raising on its own.The bed was located in the bed depot 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: 8115915
• MDR Text Key: 128898288
• Report Number: 3006697241-2018-00106
• 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: P1190A000055
• 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: 05/12/2014
• 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