FDA Adverse Event Malfunction Summary report: N

BABYLOG

MDR report key: 3885645 · Received June 9, 2014

Report

Report Number
3885645
Event Type
Malfunction
Date Received
June 9, 2014
Date of Event
May 30, 2014
Report Date
June 3, 2014
Manufacturer
DRAEGER MEDICAL GMBH
Product Code
CBK
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MI, US
Reporter Occupation
INVALID DATA

Narratives

Description of Event or Problem · 1

THE OPERATOR EXPERIENCED ALARM ASSOCIATED WITH THE OXYGEN AND NO READINGS ON THE PARAMETERS.MANUFACTURER RESPONSE:WE SENT OVER THE DEVICE LOGS TO THE MANUFACTURER AND THIS DRAEGER'S RESPONSE.POSSIBLE CAUSES = (1) WATER IN PNEUMATIC SYSTEM, (2) PARAMAGNETIC THERMAL OXYGEN (PATO) SENSOR FAULTY.REMEDIES = (1) DRY PNEUMATIC SYSTEM BY RUNNING EMPTY FOR AT LEAST FIVE MINUTES AND INSERT A DRY SAMPLING TUBE AND WATER TRAP. (2) REPLACE PATO.THIS LED TO THE OTHER PATO ERROR CODES.000292.24612 - 02 MEASUREMENT FAILURE - WATER OR REPLACE PATO SENSOR000292.24614 - WATER INSIDE THE CUVETTE.ERROR = APPARENTLY THERE IS NO WATER INSIDE THE PATO CUVETTE.TEMPORARILY FAULTY O2 MEASUREMENT UNTIL WATER HAS EVAPORATED.POSSIBLE CAUSES = (1) OCCURRED AFTER POWER-ON: CONDENSED AIR HUMIDITY. (2) OCCURRED DURING OPERATION: WATER TRAP PUNCTURED.REMEDIES = REPLACE THE WATER TRAP AS NECESSARY.ON 6/2 ERROR CODE 000292.24593 - PATO ZEROING FAILED.POSSIBLE CAUSES = ZEROING GAS IMPURE.THE ZEROING VALVE IS NOT SWITCHING. AS A RESULT PATIENT GAS IS USED FOR ZEROING.ERROR IN ABSOLUTE PRESSURE MEASUREMENT. THE OPERATING POINT OF THE PATO CHIP HEATER IS TOO IMPRECISE DURING ZEROING. THIS APPLIES IN PARTICULAR TO PATO SENSORS OLDER THAN ARWN-0000. PATO PCB FAULTY. I ORDERED AND REPLACED PATO SENSOR WHICH FIXED THE PROBLEM.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
336583 BABYLOG VENTILATOR CBK DRAEGER MEDICAL GMBH VN500 *

Patients

Seq Age Sex Outcome Treatment
1 *