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

Catalog Number	CARINA
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device posted acoustical and visual alarms indicating a device malfunction.The users replaced the device in a controlled maneuver; no patient consequences have reportedly occurred.
Additional Manufacturer Narrative
The user facility did not involve the local dräger s&s organization into examination and repair of the device.Upon dräger's request for additional information, it was responded by the hospital that no further details can be provided.This does neither allow a case-specific evaluation nor a reliable conclusion in regard to the root cause.The device was in operation for eight years now and is not under a service contract; status of repairs and preventive maintenance is not known to dräger.The ifu explains that if the self-monitoring functionality of the device detects a significant deviation and posts an alarm of type "device failure" - the user shall introduce another method of ventilation immediately.It can be derived from the user's report that this has worked as intended.The carina is a sub-acute care ventilator intended to be used on patients who are stable and require diagnostic and invasive procedures but not intensive treatment.Finally, the reported event may be related to malfunction or other factors like lack of preventive maintenance or a combination of these; a differentiation is not possible on the base of the available information.H3 other text : device not available for evaluation.

• 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
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 18355654
• Report Number: 9611500-2023-00494
• Device Sequence Number: 6426420
• Product Code: CBK
• UDI-Device Identifier: 04048675398516
• UDI-Public: (01)04048675398516(11)151014(17)160106(93)5704110-11
• Combination Product (Y/N): N
• PMA/510(K) Number: K072885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/20/2023

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: CARINA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2015
• 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