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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during use the carina had shut down.There was no patient injury reported.
Additional Manufacturer Narrative
The affected device was examined by dräger service and the log file as well as the service report were made available for further investigation at the manufacturer¿s site.As the system date was set incorrectly to a date in 2028 between april 2021 and february 2022 after a repair, it was not possible to clearly identify which log entries belong to the date of event.There were two events logged though, indicating a device shutdown due to a blower malfunction or a depleted internal battery.The second event had originally not been reported by the user.After the log file analysis further information was requested from the user regarding the potential second event.Initially the user stated that the second event did not occur during device use on a patient.However, in the further communication it was reported by the user that the second event also occurred during operating the device on a patient.The first event - device shutdown due to a blower malfunction - refers to log entry october 27, 2028 and is covered under mdr report no.: 9611500-2022-00045.If an unacceptable deviation occurs between the measured blower speed and the setpoint, the carina switches to patient safe mode, i.E.Ventilation is stopped and the high-priority alarm "device malfunction !!!" is generated.In this case, the emergency breathing valve allows the patient to breathe spontaneously.Ventilation of the patient with an independent ventilator may be required.In case the internal battery is depleted, and the device is not connected to the mains, ventilation cannot be maintained.In such a situation, the device will switch to standby mode according to the instructions for use.The internal battery of the affected device was from 2014; according to the instructions for use the battery needs to be replaced every 3 years.Finally, it was decided by the customer to scrap the carina device.Therefore, a repair of the device was not performed.In the current event, the device reacted as specified and generated appropriate alarm messages in order to alert the user of the situation.There were no patient health consequences reported.The number of similar cases concerning the reported event is within the expected range of the respective risk assessment and thus accepted.

• Brand Name: CARINA
• Common Device Name: 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
• MDR Report Key: 14785770
• Report Number: 9611500-2022-00153
• Device Sequence Number: 5074180
• Product Code: CBK
• UDI-Device Identifier: 04048675398516
• UDI-Public: (01)04048675398516(11)160616(17)160914(93)5704110-11
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/23/2022

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: 06/16/2022
• Initial Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown