MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA INFINITY ACS WORKSTATION NC; VENTILATORS, INTENSIVE CARE, NEONATAL /PEDIATRIC

Model Number	8415000
Medical Device Problem Codes	No Display/Image (1183); Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the display of the device went blank while in use on a patient.Reportedly, the ventilation continued as set.The ventilator was replaced.There were no health consequences for the patient reported.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Additional Manufacturer Narrative
The investigation was based on the provided information including a photo of the described behaviour.No log file was made available for investigation.The provided photo shows a red tint of the display.However, the graphic elements of the display are still visible.Upon request, the customer stated that the device boots up with the reddish tint, but sometime also stays completely black.Based on the available information, this can neither be confirmed nor denied.However, the available information indicates a failure of the lc display.The lc display and the inverter board were already replaced by the customer.The device displaying a reddish tint does not impact the functionality of the device.In case of a complete failure of the cockpit, a running ventilation is not affected and continues as set.Safety relevant parameters as fio2, minute volume, or airway pressure are displayed in the supplemental oled-display and the user can see the on-going ventilation.Monitoring functions and the user interface of the cockpit are not available.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
Event or Problem Description
It was reported that the display of the device went blank while in use on a patient.Reportedly, the ventilation continued as set.The ventilator was replaced.There were no health consequences for the patient reported.

• Brand Name: INFINITY ACS WORKSTATION NC
• Common Device Name: VENTILATORS, INTENSIVE CARE, NEONATAL /PEDIATRIC
• 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: 20449706
• Report Number: 9611500-2024-00439
• Device Sequence Number: 17919863
• Product Code: CBK
• UDI-Device Identifier: 04048675250418
• UDI-Public: (01)04048675250418(11)190122(93)8417400-18
• Combination Product (Y/N): N
• PMA/510(K) Number: K093632
• 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): 11/15/2024

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 Model Number: 8415000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/17/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2019
• 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