MAUDE Adverse Event Report: DRAEGERWERK AG & CO. KGAA CARINA; VENTILATOR

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	07/15/2020
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 a device error "a008" occurred while using it on a patient.There were no patient consequences reported.
Additional Manufacturer Narrative
The log file of the affected carina was analyzed for investigation.Based on the logged entries the reported problem could be confirmed.The stored error codes indicate an unacceptable deviation between measured turbine rotation speed and the set value which points to a faulty motor blower.In such a case the high priority alarm "device failure !!!" is generated and an ongoing ventilation is not continued as the device switches to patient safe mode.During this time an emergency breathing valve opens allowing spontaneous breathing of the patient.Ventilation of the patient with an independent ventilation device may be considered necessary.The device reacted as specified to the deviation by generating a visual and audible technical alarm and opening the emergency breathing valve to allow for spontaneous breathing of the patient.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 or Problem Description
Please refer to the initial report.

• Brand Name: CARINA
• Common Device Name: VENTILATOR
• Manufacturer (Section D): DRAEGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• MDR Report Key: 10400526
• Report Number: 9611500-2020-00284
• Device Sequence Number: 3094336
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2020

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: 07/15/2020
• Supplement Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 08/13/2020
• Supplement Report FDA Received Date: 09/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1