FDA Adverse Event Malfunction Summary report: N

FETALINK

MDR report key: 3760716 · Received April 1, 2014

Report

Report Number
3760716
Event Type
Malfunction
Date Received
April 1, 2014
Date of Event
March 29, 2014
Report Date
April 1, 2014
Manufacturer
CERNER CORPORATION INNOVATION CAMPUS
Product Code
HGM
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CA, US

Narratives

Description of Event or Problem · 1

MOTHER WAS IN LABOR, WITH NORMAL PROGRESSIONS FOR BOTH THE MOM AND NEONATE. THE CERNER FETALINS SYSTEM WENT DOWN AFTER POWER SURGE WITH A < 1 SECOND OUTAGE. AFTER THE SYSTEM WENT DOWN, A REGISTERED NURSE (RN) WAS ASSIGNED FULL-TIME TO THE ROOM. NEWBORN ENTERED A DISTRESSED STATE, THE RN SHOUTED FOR ASSISTANCE AND A DOCTOR WAS CALLED. STAFF SPEAKING WITH DOCTOR WAS NOT ABLE TO GIVE FULL INFORMATION FROM THE NURSES STATION AS THE CENTRAL MONITOR WAS DOWN. THE DOCTOR RESPONDED AND STARTED THE DELIVERY. FULL INFO WAS NOT AVAILABLE DURING THE DELIVERY AS THE VIEW OF THE FETAL MONITOR WAS BLOCKED BY STAFF WORKING WITH THE PATIENT. DELIVERY WAS ACCOMPLISHED SUCCESSFULLY, WITH AN APGAR OF 8/9 BECAUSE THE INFANT WAS NOTED TO HAVE A BROKEN CLAVICAL INCIDENTAL TO THE DELIVERY. THIS IS SUBMITTED AS A POTENTIAL NEAR MISS IF STAFFING DID NOT ALLOW A RN FULL TIME IN THE ROOM AFTER THE FAILURE OF THE MONITORING SYSTEM, AN ADVERSE EVENT MAY HAVE OCCURRED. THE PROBLEM WITH THE SYSTEM WAS THE POWER FAILURE CHANGED THE TIME ON ONE OF THE CERNER DEVICES TO OUTSIDE THE +/- 30 SECOND WINDOW PERMITTED. IT RESOLVED THE ISSUE IN APPROXIMATELY 2 HOURS (EASY FIX, TROUBLESHOOTING TOOK SOME TIME) USING A COLLABORATIVE TEAM, CERNER, CORPORATE IT, INFORMATICS, BIOMEDICAL STAFF. MANUFACTURER IS INVOLVED IN RESOLUTION OF THE PROBLEM. AS STATED ABOVE THIS IS A HEADS-UP REGARDING TECHNOLOGY FAILURE AND THE POTENTIAL FOR SIGNIFICANT PATIENT HARM. OUTCOME ON THIS PROCEDURE WAS NOT SIGNIFICANTLY CHANGED BY THE FAILURE OF THE EQUIPMENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
193463 FETALINK SYSTEM, MONITORING, PERINATAL HGM CERNER CORPORATION INNOVATION CAMPUS * *

Patients

Seq Age Sex Outcome Treatment
1 * SYSTEM FAILURE, MULTIPLE DEVICES INCLUDING IN-ROOM| OFF-SITE IT EQUPMENT.| FETAL MONITOR, CENTRAL MONITOR ON-SITE AND