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

Model Number P1190A000091

Device Problem Unintended Movement (3026)

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

Event Date 07/18/2023

Event Type  malfunction  

Event Description

Hillrom received a report from a hillrom technician stating the head of the bed was rising spontaneously.The bed was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as (b)(4).

Manufacturer Narrative

The hillrom technician found the siderail cable needed to be replaced.Per the hillrom 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 the head and foot side rails are not bent or twisted.Make sure the latch mechanism operates correctly.An audible click must be heard.Remove the side rail cover, and make sure the mounting screws are tight.Inspect the cable routing for pinching, binding, and damage.Make sure all functions on the caregiver control operate correctly.Repair or replace the side rail as necessary.A search of the hillrom maintenance records showed hillrom performed preventative maintenance on this bed on aug 27, 2021.It is unknown if the facility performed any other preventative maintenance on this bed.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: maritza valencia ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 17549210
• MDR Text Key: 321347509
• Report Number: 3006697241-2023-00082
• 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: 08/15/2023

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 Model Number: P1190A000091
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/18/2023
• Initial Date FDA Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2014
• 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