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

Catalog Number	5704110
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	03/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility did not involve the local dräger s&s organization into any follow-up measures and did not provide additional information upon request.A case-specific evaluation is thus not possible, only a general assessment can be made.It could even not be clarified if the unit stopped ventilating or if it fully shut down.Hence, the simpliest explanation would be that the unit ran on internal battery until the latter was depleted.Other explanations may however apply as well and, a differentiation is not possible due to lack of information.The device was in operation for more than 8 years now and is not under a service contract, status of preventive maintenance and repairs is thus unknown.The carina is intended for treatment of sub-acute care patients in hospital or medical rooms i.E.The patients must be stable and shall not require intensive treatment.The device is designed to post an alarm if the self-monitoring functionality of the device detects a deviation - this was ensured during the particular event; the device has reportedly alarmed.Technical deviations with the device but also use error or lack of maintenance must be taken into consideration as contributing factors in the event but further conclusions can't be made.It is recommended to the hospital to have the device checked by trained service personnel.H3 other text : device not available for evaluation.
Event or Problem Description
It was reported that the device suddenly "stopped running".As per report, the patient experienced a temporary desaturation which was removed quickly after the introduction of a replacement device.No health consequences have occurred, finally.

• 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: 19257973
• Report Number: 9611500-2024-00198
• Device Sequence Number: 16796402
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 05/07/2024
• 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