MAUDE Adverse Event Report: HILL-ROM MEXICO ADVANTA 2 FRAME; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number P1190A000052

Device Problem Self-Activation or Keying (1557)

Patient Problem No Patient Involvement (2645)

Event Date 12/10/2020

Event Type  malfunction  

Manufacturer Narrative

The hillrom technician found the interface board , foot and head motor needed to be replaced.It is necessary for the progressa¿ bed to have an effective maintenance program.We recommend that you do annual preventive maintenance disconnect the patient pendant and examine the condition of the connector.Then connect or replace the pendant.Press each of the controls to make sure that they engage the correct function and they do not work intermittently.Each movement must be continuous.Troubleshoot in the event of a doubt.A search of the hillrom maintenance records did not show hillrom performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.The technician replaced the interface baord , foot and head motor to resolve the issue.Based on this information, no further action is required.

Event Description

Hillrom received a report from a hillrom technician stating the head of the bed was going up by itself.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).

• Brand Name: ADVANTA 2 FRAME
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): HILL-ROM MEXICO; ave.del telefono no. 200 col. huinala; apodaca, nuevo leon 66640 ; MX 66640
• Manufacturer Contact: harish vishwanathan ; 1069 state route 46 east; batesville, IN 47006 ; 3127289851
• MDR Report Key: 11012531
• MDR Text Key: 223183514
• Report Number: 3006697241-2020-00093
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122473
• 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: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: P1190A000052
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2012
• 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