MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY DELTA; PHYSIOLOGICAL MONITORING SYSTEMS

Model Number	MS18597
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the unit was not alarming during vfib (ventricular fibrillation).No adverse patient impact was reported.The hospital biomed was unable to duplicate the reported malfunction upon initial testing.The device was returned to draeger for evaluation.It was additionally noted that the device chassis was damaged.The biomed stated no further information was available regarding the event.Note that the initial service request reported a "case cracked - not alarming during dfib".During further review of the service order, additional information was requested for symptom clarification and the above information was received on 10mar2022 from the hospital biomed clarifying that the device failed to alarm for vfib.
Additional Manufacturer Narrative
The device was evaluated by draeger and the reported issue could not be reproduced.As a precaution, based on the reported symptom, the main processor board was replaced.The reported damaged parts were repaired (rear housing, bezel, language label and battery door) and the backlights were replaced due to the display being dim.Without device logs/settings and full disclosure/waveforms from the event, the cause of the device no alarming for vf cannot be determined.The instructions for use delta/delta xl/kappa vf9 (ifu) provides the criteria for vf detection: vf ventricular fibrillation: the monitor identifies a sinusoidal waveform with fibrillation characteristics (1).Certain ventricular tachycardias have sinusoidal waveforms closely resembling those of ventricular fibrillation.Because of the similarity of these waveforms, the monitor may classify such types of ventricular tachycardia as ventricular fibrillation, the more serious of the two conditions.Additionally, the following is provided regarding device damage: warning - if the device is mechanically damaged, or if it is not working properly, do not use it.Contact your hospital¿s technical personnel.

• Brand Name: INFINITY DELTA
• Common Device Name: PHYSIOLOGICAL MONITORING SYSTEMS
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 6 tech drive; andover MA
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC; 6 tech drive; andover MA
• MDR Report Key: 14032059
• Report Number: 1220063-2022-00004
• Device Sequence Number: 4613379
• Product Code: MHX
• UDI-Device Identifier: 04049098004152
• UDI-Public: 04049098004152
• Combination Product (Y/N): N
• PMA/510(K) Number: K152407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 04/06/2022

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 Model Number: MS18597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2013
• 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