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

Model Number	8417400
Medical Device Problem Codes	Restricted Flow rate (1248); Inaccurate Flow Rate (1249); Medical Gas Supply Problem (2985); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during operation in simv, suddenly apnea alarm rang and ventilation "0" was displayed on the screen.After replacing the device, performed system check.Pressure sensor valve, expiratory valve, and safety valve were indicating errors.No patient injury has been 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 reported event, logfile analysis and information incl.Video from onsite investigation by dräger service technician of the affected infinity acs workstation nc device.According to the investigation of the logfile, it could be confirmed that the air pressure alarmed of "0" at the reported time.No patient health consequences have been reported.The device alarmed and behaved as specified.A deviation of the measured o2 and the set o2 is listed in the debug log and a faulty pato could not confirmed by log.This supports the assumption of a temporary insufficient air supply.The hospital technician could reproduce the event and replaced the expiratory valve and breathing circuit system.When draeger service engineer checked the device according to manufacturer specs again the symptom could not reproduced.The logfile showed multiple entries e.G.
Event or Problem Description
It was reported that during operation in simv, suddenly apnea alarm rang and ventilation "0" was displayed on the screen.After replacing the device, performed system check.Pressure sensor valve, expiratory valve, and safety valve were indicating errors.No patient injury has been 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: 20222712
• Report Number: 9611500-2024-00383
• Device Sequence Number: 20784017
• Product Code: CBK
• UDI-Device Identifier: 04048675250418
• UDI-Public: (01)04048675250418(11)150226(93)8417400-13
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2024

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: 8417400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2024
• Supplement Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.; NA.
• Patient Sex: Unknown