FDA Adverse Event Malfunction Summary report: N

ADVANTA BED

MDR report key: 4077246 · Received August 21, 2014

Report

Report Number
3006697241-2014-00624
Event Type
Malfunction
Date Received
August 21, 2014
Date of Event
July 26, 2014
Report Date
July 26, 2014
Manufacturer
HILLROM DE MEXICO S DE RL DE CV
Product Code
FNL
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
CT, US
Reporter Occupation
UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

THE HILL-ROM TECHNICIAN FOUND THE SIDECOM CABLE HAD BROKEN PINS. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2013. IT IS UNKNOWN IF THE FACILITY PERFORMED PREVENTIVE ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE SIDECOM COMMUNICATION BOARD TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

Description of Event or Problem · 1

HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING NURSE CALL IS NOT FUNCTIONING. THE BED WAS LOCATED AT THE ACCOUNT IN ENGINEERING. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
504785 ADVANTA BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILLROM DE MEXICO S DE RL DE CV 1190

Patients

Seq Age Sex Outcome Treatment
1