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

Model Number P1190A000048

Device Problem Unintended Movement (3026)

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

Event Date 10/13/2021

Event Type  malfunction  

Manufacturer Narrative

The hillrom technician found damage to the head down button on the left head caregiver pcb.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 hillrom maintenance records showed hillrom performed preventative maintenance on this bed in (b)(6) 2021.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the left caregiver control.Based on this information, no further action is.

Event Description

Hillrom received a report from a hillrom technician stating the head of the bed was moving down 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 #: c-(b)(4).

• 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: 12657008
• MDR Text Key: 277723218
• Report Number: 3006697241-2021-00091
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: P1190A000048
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2011
• 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