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	12/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Event or Problem Description
It was reported that the carina device generated the alarm message "device error" twice at around 11.32 p.M.On the (b)(6) 2021 and as a result ventilation was no longer possible.No patient consequences were reported.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Event or Problem Description
It was reported that the carina device generated the alarm message "device error" twice at around 11.32 p.M.On the (b)(6) 2021 and as a result ventilation was no longer possible.No patient consequences were reported.
Event or Problem Description
It was reported that the carina device generated the alarm message "device error" twice at around 11.32 p.M.On the (b)(6) 2021 and as a result ventilation was no longer possible.No patient consequences were reported.
Additional Manufacturer Narrative
The affected device, carina, serial number: (b)(6), was examined in the manufacturer's repair shop; the log file was also provided for further investigation.Based on the log file analysis, it could be confirmed that the device switched from an ongoing ventilation to "patient safe" mode at 11:27 p.M.And 11:32 p.M.On (b)(6) 2021; between the two events, the device was turned off and back on by the user.Previously, an excessive minute volume and a leakage had also been alerted.As a result of the investigation in the repair shop, a malfunction of the blower function was confirmed in addition to a large leakage and contact problems of the device.If a serious technical fault with device failure occurs during operation, the device switches to "patient safe" mode and ventilation is interrupted.The "device fault !!!" is alerted visually and acoustically by the device with high priority.The emergency breathing valve opens and allows the patient to breathe spontaneously.Ventilation of the patient with an independent ventilation device may be required.In the current case, the device reacted as specified and generated alarms regarding the detected deviations and the device malfunction.The affected parts were replaced in the course of the repair measures; the device was then tested according to the manufacturer's specifications and is fully functional again.The number of similar cases, related to the same root cause, 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: 13176027
• Report Number: 9611500-2022-00004
• Device Sequence Number: 12086976
• Product Code: CBK
• UDI-Device Identifier: 04048675398516
• UDI-Public: (01)04048675398516(11)160725(17)161018(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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2022

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2021
• Supplement Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 03/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2016
• 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