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

Model Number 1190

Device Problems Device Alarm System (1012); Device Sensing Problem (2917)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/16/2014

Event Type  malfunction  

Event Description

Hill-rom received a report from a hill-rom technician stating the nurse call would not send a signal.Bed was located on the floor at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

The hill-rom technician found the communication cable was damaged.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in 2014.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the communication cable to resolve the issue.Based on this information, no further action is required.

• Brand Name: ADVANTA 2 BED
• Type of Device: A/C POWWERD ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): HILLROM DE MEXICO S DE RL DE CV; apodaca ; MX
• Manufacturer Contact: tony werner ; 1069 state route 46 east; batesville, IN 47006 ; 8129312359
• MDR Report Key: 3958645
• MDR Text Key: 4622379
• Report Number: 3006697241-2014-00450
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2014
• 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: 04/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2011
• 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