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

Catalog Number	5704110
Medical Device Problem Codes	Gas Output Problem (1266); Decreased Pump Speed (1500); Failure to Deliver (2338)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	03/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The log file of the affected device was analyzed.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.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 by generating the corresponding optical and acoustical alarms.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
It was reported that a patient was connected to the carina to support patient's breathing, carina started to work normally but suddenly the device informed malfunction and stopped operation.Carina shut down and restarted.It restarted for seconds and shut down by itself.This happened several times.Patient saturation was low as 80% and below, and patient had difficulties to breath so cpap was really needed.New carina was brought for patient and it worked normally.Patient had few minutes break in cpap treatment.No further consequences reported.

• Brand Name: CARINA
• Common Device Name: VENTILATORS, OTHER
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 9887641
• Report Number: 9611500-2020-00100
• Device Sequence Number: 19358258
• Product Code: CBK
• UDI-Device Identifier: 04048675041610
• UDI-Public: (01)04048675041610(11)191118(17)200209(93)8419350-35
• 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
• Report Date (Section B): 03/27/2020

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: 5704110
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2020
• Initial Report FDA Received Date: 03/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1