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

Catalog Number	8419350
Medical Device Problem Codes	Gas Output Problem (1266); Decreased Pump Speed (1500); Failure to Deliver (2338)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation was just started.The results will be provided in a follow-up report.
Event or Problem Description
It was reported that the device posted device failure with a008 alarm while in use on patient.No injury reported.
Additional Manufacturer Narrative
For the investigation the logfile was analysed.It was found that during ventilation the device found inconsistencies between the measured turbine rotation speed of the motor blower and the set rotation speed.As specified for this case, the device posted the technical alarm "blower defect" (00.A008) and the device switched to patient safe mode.In this case the ventilation stops and the high priority alarm "device failure !!!" will be given.The emergency breathing valve opens allowing spontaneous breathing of the patient.Ventilation of the patient with an independent ventilation device may be considered necessary.It was not possible to determine the root cause for the rotation speed deviations.Carina reacted as specified for this situation and gave the corresponding optical and acoustical alarms.
Event or Problem Description
Please refer to the initial-report.

• Brand Name: CARINA
• Common Device Name: VENTILATORS, OTHER
• Manufacturer (Section D): DRAEGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• MDR Report Key: 10094993
• Report Number: 9611500-2020-00180
• Device Sequence Number: 16979861
• Product Code: CBK
• UDI-Device Identifier: 04048675041610
• UDI-Public: (01)04048675041610(11)160919(17)161127(93)8419350-28
• Combination Product (Y/N): N
• PMA/510(K) Number: K072885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2020

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
• Operator of Device: Health Professional
• Device Catalogue Number: 8419350
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/01/2020
• Supplement Date Received by Manufacturer: 06/12/2020
• Initial Report FDA Received Date: 05/28/2020
• Supplement Report FDA Received Date: 07/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NA.; NA.