FDA Adverse Event Injury Summary report: N

MAQUET

MDR report key: 1661568 · Received April 13, 2010

Report

Report Number
MW5015559
Event Type
Injury
Date Received
April 13, 2010
Date of Event
April 12, 2010
Report Date
April 13, 2010
Manufacturer
MAQUET, INC.
Product Code
CBK
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
IN, US
Reporter Occupation
RESPIRATORY THERAPIST

Narratives

Description of Event or Problem · 1

AT APPROX 0920 -CDT- ON THE MORNING OF (B) (6) 2010, PATIENT (B) (6). FEMALE IN THE INTENSIVE CARE UNIT WAS CONNECTED TO THIS VENTILATOR WITH COMMON ADULT PARAMETERS OF: ASSIST/CONTROL -PRVC- MODE, RESP RATE 12 BPM, TIDAL VOLUME 500ML, PEEP +5 CWP AND FIO2 .50. THE RESPIRATORY CARE PRACTITIONER -RCP- STATED THE INITIAL ASSESSMENT AND PARAMETER CHECKS WERE "IN COMPLIANCE". AFTER APPROX 20 MINS THE VENTILATOR WENT INTO AN ALARM CONDITION FOR "LOW PEEP". SINCE THE PT WAS IN THE PROCESS OF A BEDSIDE PROCEDURE, AND WAS IN A STABLE CONDITION, THE RCP ELECTED TO RESET THE ALARMS AND REEVALUATE THE SITUATION AFTER THE PROCEDURE. APPROX 20 MINS LATER, THE PROCEDURE RADIOGRAPHER SUMMONED THE ATTENDING NURSE AND STATED THE PT APPEARED TO BE "NOT GETTING ANY AIR". THE NURSE BRIEFLY EVALUATED THE SITUATION, NOTING THE SERVO VENTILATOR WAS NOT CYCLING/TRIGGERING AND AGREED. SHE IMMEDIATELY DISCONNECTED THE PT FROM THE VENTILATOR AND BEGAN MANUAL VENTILATION WITH THE BEDSIDE RESUSCITATION BAG, WHICH WAS CONNECTED TO 100% OXYGEN. AT THIS POINT, THE RCP WAS CALLED STAT FOR ASSISTANCE. AS THE RN CONTINUED MANUALLY BREATHING THE PT, HE EXAMINED THE VENTILATOR TO TROUBLESHOOT IT FOR PROBLEMS. HE NOTED THE SAME PROBLEM, ADVISED THE RN TO CONTINUE VENTILATING THE PT AND CALLED THE RESPIRATORY CARE DEPT FOR ASSISTANCE TO SET UP A REPLACEMENT VENTILATOR. THIS WAS ACCOMPLISHED AFTER THE PROCEDURE COMPLETION, ABOUT 15 MINS LATER, WITHOUT FURTHER INCIDENT. THE PT DID NOT EXPERIENCE ANY NEGATIVE EFFECTS FROM THIS EVENT. A SUBSEQUENT BLOOD GAS ANALYSIS WAS ACCEPTABLE. LATER REVIEW OF THE DEVICE PLUS, THIS REPORTER'S INTERVIEW WITH THE ATTENDING PROFESSIONAL STAFF YIELDED THE FOLLOWING INFO: THE VENTILATOR UNEXPECTEDLY FAILED TO CYCLE EITHER BY TIME OR PT INSPIRATION -FLOW TRIGGER SET AT GREEN #5-. THE FIO2, SET AT .50, WAS DISPLAYED AS .21 -ROOM AIR VALUE- ON THE MONITORING SCREEN. THE MONITORING/ALARMS WERE FUNCTIONING ACCEPTABLY, AS EVIDENCED BY STRAIGHT LINE WAVEFORMS DURING THE EVENT AND ACTIVE ALARMS FOR APNEA, LOW O2, LOW PEEP, LOW PRESSURE AND LOW MIN VOLUME. THE SAFETY VALVE DID OPEN, ALLOWING FOR ROOM AIR TO BE DRAWN THROUGH THE CLOSED CIRCUIT, AS TRIED BY THIS REPORTER AFTER THE EVENT. ALL OF THESE FINDINGS WERE CONFIRMED AFTERWARD WITH A BRIEF "BENCH TEST" IN THE RESPIRATORY CARE DEPT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MAQUET SERVO I VENTILATOR CBK MAQUET, INC. 6487800

Patients

Seq Age Sex Outcome Treatment
1 78 YR Life Threatening