FDA Adverse Event Malfunction Summary report: N

BABYSAFE

MDR report key: 1032723 · Received March 31, 2008

Report

Report Number
1032723
Event Type
Malfunction
Date Received
March 31, 2008
Date of Event
March 20, 2008
Report Date
March 28, 2008
Manufacturer
VITAL SIGNS, INC.
Product Code
BTM
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MN, US

Narratives

Description of Event or Problem · 1

FULL TERM BABY WAS TAKEN TO RADIOLOGY FOR A MRI OF THE BRAIN. PRIOR TO ENTERING THE MRI SUITE, THE PATIENT WAS BEING VENTILATED BY DISPOSABLE BAG. BABY WAS NOTED TO HAVE GOOD CHEST RISE AND SATS. BABY WAS THEN MOVED FROM TRANSPORTER TO MRI TABLE. RESPIRATORY CARE STAFF CHANGED TUBING SET-UP IN PREPARATION FOR EXAM. TUBING HAD ETT ADAPTER, OXYGEN SOURCE WAS CLOSE TO ETT ADAPTER AND LONG, CORRUGATED TUBING WAS ATTACHED TO THE PEEP VALVE AND ANESTHESIA BAG. MRI BED WAS MOVED TO "ENGAGE" POSITION, AND RESPIRATORY CARE PRACTITIONER (RCP) HEARD A CLICK. IT WAS IMMEDIATELY IDENTIFIED THAT CORRUGATED BREATHING TUBE HAD BEEN CAUGHT AND PINCHED BY THE BED LATCH. BED WAS QUICKLY MOVED BACK AND BABY CONTINUED TO BE MANUALLY BAGGED. APPROXIMATELY THIRTY SECONDS LATER, BABY WAS NOTED TO HAVE COLOR CHANGE. THE PATIENT WAS AUSCULTATED IMMEDIATELY WITH STETHOSCOPE AND WAS FELT TO NOT BE INTUBATED, NO BREATH SOUNDS WERE HEARD. NEONATE NURSE PRACTITIONER (NNP) NOTIFIED IMMEDIATELY AND BABY WAS TAKEN OUT INTO THE HALLWAY AND BAGGING WAS IMMEDIATELY STARTED. BABY WAS QUICKLY INTUBATED AND MONITOR REVEALED IMPROVING HEART RATE AND SATS. CREPITUS BEGAN APPEARING ON THE UPPER CHEST AND INTO NECK AND BACK OF HEAD. NEEDLE ASPIRATION WAS PERFORMED AND AIR WAS ASPIRATED ON BOTH THE RIGHT AND LEFT SIDE. BABY WAS TRANSFERRED BACK TO THE NICU AND PLACED BACK ON NICU VENTILATOR.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 BABYSAFE RESUCITATOR SYSTEM BTM VITAL SIGNS, INC. 5503 *

Patients

Seq Age Sex Outcome Treatment
1 2 WK