MAUDE Adverse Event Report: HILL-ROM MEXICO ADVANTA2 RENTAL BED; BED, MANUAL

Model Number P1190ARENT01

Device Problem Unintended Movement (3026)

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

Event Date 03/17/2022

Event Type  malfunction  

Manufacturer Narrative

The hillrom technician found the casters needed to be replaced.Per the hillrom service manual, perform annual preventive maintenance procedures to make sure all bed components are functioning as originally designed.Brake casters should be checked for cuts, wear and quality of tread, etc.And replaced when necessary.Examine the brakes to see whether the bed moves when the brakes are set.Replace as necessary.A search of the hillrom maintenance records showed hillrom performed preventative maintenance on this bed in august 2021.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the casters to resolve the issue.Based on this information, no further action is required.On june 1, 2022 additional information was received that corrected the product information from the p500 surface (manufactured in hill-rom (b)(4)) to the advanta 2 bed (manufactured in hill-rom mexico).Hillrom initially reported this event under report 1824206-2022-00200 submitted on april 13, 2022.This is a supplement report to reflect the corrected product information.

Event Description

Hillrom received a report from a hillrom technician stating the bed brakes were not holding.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).On june 1, 2022 additional information was received that corrected the product information from the p500 surface (manufactured in hill-rom (b)(4)) to the advanta 2 bed (manufactured in hill-rom mexico).Hillrom initially reported this event under report 1824206-2022-00200 submitted on april 13, 2022.This is a supplement report to reflect the corrected product information.

• Brand Name: ADVANTA2 RENTAL BED
• 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: brad wheeler ; 1069 state route 46 east; batesville, IN 47006 ; 3128199307
• MDR Report Key: 14573068
• MDR Text Key: 301634845
• Report Number: 3006697241-2022-00032
• 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: 06/02/2022

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: P1190ARENT01
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/17/2022
• Initial Date FDA Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2012
• 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