FDA Adverse Event Malfunction Summary report: N

SERVO-U

MDR report key: 17926710 · Received October 12, 2023

Report

Report Number: 8010042-2023-01974
Event Type: Malfunction
Date Received: October 12, 2023
Date of Event: September 19, 2023
Report Date: October 12, 2023
Manufacturer: MAQUET CRITICAL CARE AB
Product Code: CBK
UDI-DI: 07325710001110
PMA / PMN Number: K201874
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: LA, US
Reporter Occupation: OTHER
Health Professional: N

Narratives

Additional Manufacturer Narrative · 0

IT WAS REPORTED THAT THE VENTILATOR HAD PRESSURE FLOW TRANSDUCER ISSUE. NO MORE INFORMATION WAS AVAILABLE. THE VENTILATOR WAS INVESTIGATED ON SITE BY OUR FIELD SERVICE ENGINEER WHO CONFIRMED THE REPORTED FAILURE. ISSUE WAS RESOLVED BY REMOVING AND CLEANING THE EXPIRATORY VALVE WITH WATER. AFTER PLACING THE CLEANED EXPIRATORY VALVE BACK INTO THE UNIT IT PASSED ALL FUNCTIONAL TESTS AND WAS HANDED BACK TO CUSTOMER IN WORKING CONDITION. HOWEVER, DESPITE SEVERAL REMINDERS, DEVICE LOGS WERE NOT PROVIDED. THEREFORE, NO ROOT CAUSE CAN BE ESTABLISHED. PRESSURE TRANSDUCER TEST CALIBRATES AND CHECKS THE INSPIRATORY AND EXPIRATORY PRESSURE TRANSDUCERS. THE NEW ZERO VALUE FOR THE PRESSURE TRANSDUCERS MAY NOT DIFFER MORE THAN ±5 CMH2O FROM FACTORY CALIBRATION. DURING THIS TEST, THE DIFFERENT SUBSYSTEMS CONCERNED ARE COMPARED. THE DIFFERENCE BETWEEN THE SUB-SYSTEMS MUST NOT BE MORE THAN ±1 CMH2O AT 60 CMH2O.

Description of Event or Problem · 0

IT WAS REPORTED THAT THE VENTILATOR HAD PRESSURE FLOW TRANSDUCER ISSUE. NO MORE INFORMATION WAS AVAILABLE. THERE WAS NO PATIENT HARM REPORTED. MANUFACTURER'S REF. #: 894906

Description of Event or Problem · 0

MANUFACTURER'S REF. #: (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1415460	SERVO-U	VENTILATOR, CONTINUOUS, FACILITY USE	CBK	MAQUET CRITICAL CARE AB	SERVO-U		07325710001110

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown