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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2024

Event Type  malfunction  

Manufacturer Narrative

The affected device was tested by dräger service and the log file was secured for analysis.Based on the log entries that the device started performing a ventilation on (b)(6) 2024 at 17:02.At 21:35 logged the error code 00.A008 faulty blower and the device switched to patient safe mode.At 21:50 the device was switched off by the user.During the device test the device failure could not be reproduced.Two unrelated issues were found and repaired ¿ a missing wheel at the trolley and a battery that could not be fully charged.Afterwards the device passed a full functional test according to manufacturer specification.Based on the investigation results the issue regarding the blower performance was temporary and the exact root cause could not be determined.No persistent malfunction was found.If an unacceptable deviation between measured turbine rotation speed and the set value will be recognized during ventilation the technical alarm "faulty blower" (00.A008) will be reported and the device will switch to patient safe mode.In this mode the ventilation stops and the high priority alarm "device failure !!!" will be given.During this time an emergency breathing valve would open allowing spontaneous breathing of the patient.Ventilation of the patient with an independent ventilation device may be considered necessary.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 during a case the ventilation stopped.No patient injury was reported.

• Brand Name: CARINA
• Type of Device: VENTILATORS, OTHER
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 18992311
• MDR Text Key: 338881509
• Report Number: 9611500-2024-00134
• 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: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1