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

Catalog Number	5704110
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event was reported by the user facility to the national authority only draeger was not involved in device check or analysis of the reported event.The device was manufactured in (b)(6) 2017 and is not under maintenance contract with draeger no further information could be obtained.Due to the very little information the manufacturer is not able to investigate or to draw a conclusion about the root cause of the event or if appropriate measures and repairs have been performed after the event.Under consideration that the event occured during transport the environmental and use condition may be relevant, like impact/collision or disconnections of cable or hoses to the device.Finally no reliable conclusion can be given the case was closed due to insufficient information.H3 other text : device not available for investigation, 3rd party service.
Event or Problem Description
It was reported that the patient was connected to the sub acute ventilator and ventilated while being transported for an external examination.On the way back to the department the ventilator suddenly showed a white screen and did not work normal.The patient was immediately supported by a breathing bag and connected to another ventilator at arrival on the ward.No injury or serious impairment of patient´s state of health was reported.

• 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: 18864959
• Report Number: 9611500-2024-00100
• Device Sequence Number: 8283264
• Product Code: CBK
• UDI-Device Identifier: 04048675398516
• UDI-Public: (01)04048675398516(11)170816(17)171228(93)5704110-12
• 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): 03/08/2024

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: 02/21/2024
• Initial Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown