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

Model Number	5704110
Medical Device Problem Codes	Premature Discharge of Battery (1057); Failure to Deliver (2338); Complete Loss of Power (4015)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reportedly the hospitals engineer checked the device and identified a battery failure that prevented normal charging and discharging - the battery was replaced.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 affected device was manufactured in november 2019 and is not under maintenance contract with draeger - no further information could be obtained.The manufacturer is not able to perform an investigation to either confirm or deny the reported event.It is not possible to draw a reliable conclusion about the root cause of the event or if appropriate measures and repairs have been performed after the event.It must be clearly remarked that batteries are subject to maintenance and exchange according to the device instructions.The maintenance state of the affected battery is unknown.The charge indicator of the battery is not appropriate to check its maintenance state ¿ an overaged battery may not be capable to supply the device with energy despite being indicated as fully or sufficiently charged.
Event or Problem Description
It was reported that, while being on patient transport, the ventilator suddenly alarmed, then powered off and could not be turned on again.The patient was immediately ventilated by a breathing bag and re-connected to another ventilator - no injury or serious impairment of patients state of health was reported.

• Brand Name: CARINA
• Common Device Name: VENTILATORS, INTENSIVE CARE
• 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: 21176987
• Report Number: 9611500-2025-00041
• Device Sequence Number: 18300182
• Product Code: CBK
• UDI-Device Identifier: 04048675398516
• UDI-Public: (01)04048675398516(11)191210(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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/17/2025

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 Model Number: 5704110
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2019
• 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