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 Problems Sticking (1597); Device Stops Intermittently (1599)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2014

Event Type  malfunction  

Event Description

Hill-rom received a report from the account stating the cpr function was intermittent and sticking upon delivery.The bed was located at the account.No report of serious injury or death.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

The hill-rom technician found the head drive was defective.A search of the hill-rom maintenance records did not show hill-rom performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.The technician replaced the head drive and the issue was resolved.Based on this information, 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; ave.del telefono no. 200 col. huinala; apodaca 0000 ; MX 0000
• Manufacturer Contact: tony werner ; 1069 state route 46 east; batesville, IN 47006 ; 8129312359
• MDR Report Key: 4390487
• MDR Text Key: 17263625
• Report Number: 3006697241-2014-00773
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 12/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2014
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1