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

Model Number P1190A000266

Device Problem Unintended Movement (3026)

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

Event Date 11/06/2023

Event Type  malfunction  

Event Description

Baxter received a report from a baxter technician stating the bed head would rise up on its own.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

The baxter technician found the siderail cable needed to be replaced.A search of the baxter maintenance records showed baxter performed preventative maintenance on this bed on (b)(6), 2023 it is unknown if the facility performed any other preventative maintenance on this bed.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.The technician replaced the siderail cable 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 66640 ; MX 66640
• Manufacturer Contact: estephania cardenas ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 18136399
• MDR Text Key: 328121264
• Report Number: 3006697241-2023-00127
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: P1190A000266
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2017
• 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