MAUDE Adverse Event Report: HILLROM DE MEXICO S DE RL DE CV ADVANTA 2 BED; A/C POWERED ADJUSTABLE HOSPITAL BED

Model Number 1190

Device Problem Positioning Problem (3009)

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

Event Date 04/24/2014

Event Type  malfunction  

Event Description

Hill-rom technical support received a report from the account stating the pt positioning module would not set.The bed was located in the bed shop.There was no pt/user injury reported.This report was filed in our complaint handling system as complaint # 130218.

Manufacturer Narrative

The hill-rom technical support rep performed troubleshooting over the phone with the account, asking the account to isolate the left and right scale pods and making sure the pt is centered in the bed.A search of the hill-rom maintenance records did not show hill-rom performed any preventative maintenance on this bed.It is unk if the facility performs preventative maintenance on their beds.Hill-rom technical support found the account did not have the pt centered.The account centered the pt and the pt positioning module was able to set.Based on this info, no further action is required.

• Brand Name: ADVANTA 2 BED
• Type of Device: A/C POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): HILLROM DE MEXICO S DE RL DE CV; apodaca ; MX
• Manufacturer Contact: tony werner ; 1069 state rt 46 e; batesville, IN 47006 ; 4129312359
• MDR Report Key: 3896799
• MDR Text Key: 4672600
• Report Number: 3006697241-2014-00473
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2014

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 Operator: Other
• Device Model Number: 1190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/24/2014
• Initial Date FDA Received: 05/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2012
• 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