MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA CARINA; VENTILATORS, OTHER

Catalog Number 5704110

Device Problems Gas Output Problem (1266); Decreased Pump Speed (1500); Failure to Deliver (2338)

Patient Problem Insufficient Information (4580)

Event Date 03/06/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started.Results will be provided in a follow-up report.

Event Description

It was reported that the device alarmed with error 'device failure' and stopped ventilating.There was no patient injury reported.

Manufacturer Narrative

The reported information and the provided log file were analyzed.The logbook shows the error codes 00.A008 (faulty blower) and 00.A018 (faulty pressure sensor) during the reported time of event.The exact root cause of the error codes could not be determined as there was no further information or parts received.In case of a blower defect, the device switches into patient safe mode which means that the emergency breathing valve is opened to allow spontaneous breathing of the patient.This device behaviour could be seen in this case in the log file.In case of an isolated pressure sensor fault, the device switches to rescue ventilation and alarms accordingly.Rescue ventilation is a pressure-controlled ventilation mode with reduced quality.A faulty pressure sensor may also lead to the failure of the blower as it is used to measure the turbine rotation speed.The device behaved as specified by switching into patient safe mode.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

Event Description

It was reported that the device alarmed with error 'device failure' and stopped ventilating.There was no patient injury reported.

• Brand Name: CARINA
• Type of Device: VENTILATORS, OTHER
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 11587721
• MDR Text Key: 246006452
• Report Number: 9611500-2021-00134
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K072885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5704110
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/10/2021
• Initial Date FDA Received: 03/30/2021
• Supplement Dates Manufacturer Received: 04/01/2021
• Supplement Dates FDA Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1