MAUDE Adverse Event Report: HILL-ROM MEXICO ADVANTA 2 FRAME; BED, MANUAL

Model Number P1190A000052

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2023

Event Type  malfunction  

Event Description

Baxter received a report from a customer stating the bed head section was raising with no buttons pressed.The bed was located 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

Upon remote inspection, baxter technician found the hand pendants needed to be replaced.Per the hillrom service manual the advanta¿ 2 should be subject to an effective maintenance program.Test each of the buttons to check that they activate the correct function and that they do not work intermittently by pressing each button for several seconds.Each movement must be continuous.Replace the pendant if necessary.A search of the baxter maintenance records did not show baxter performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.The technician replaced the hand pendants to resolve the reported event.Based on this information, no further action is required.

• Brand Name: ADVANTA 2 FRAME
• Type of Device: BED, MANUAL
• Manufacturer (Section D): HILL-ROM MEXICO; ave.del telefono no. 200 col. huinala; apodaca, nuevo leon
• Manufacturer Contact: daniela avila ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 18336178
• MDR Text Key: 330610321
• Report Number: 3006697241-2023-00141
• Device Sequence Number: 1
• Product Code: FNJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: P1190A000052
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2018
• 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