MAUDE Adverse Event Report: HILL-ROM MEXICO ADVANTA 2 FRAME; A/C POWERED ADJUSTABLE HOSPITAL BED

Model Number P1190A000082

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/23/2017

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician found the load beams needed to be replaced.Per the hill-rom user manual, warning: the bed exit alarm system is not intended as a substitute for good nursing practices.The bed exit alarm system must be used in conjunction with a sound risk assessment and protocol a search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in 2017.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the load beams to resolve the issue.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating the bed exit is not alarming 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: A/C POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): HILL-ROM MEXICO; ave.del telefono no. 200 col. huinala; apodaca, nuevo leon 66640 ; MX 66640
• Manufacturer Contact: tony werner ; 1069 state route 46 east; batesville, IN 47006 ; 8129312359
• MDR Report Key: 7052210
• MDR Text Key: 93582095
• Report Number: 3006697241-2017-00117
• Device Sequence Number: 1
• Product Code: FNL
• 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: Hospital Service Technician
• Type of Report: Initial
• Report Date: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: P1190A000082
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1