MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY ACUTE CARE SYSTEM (M540); PHYSIOLOGICAL MONITORING SYSTEMS

Catalog Number	MS25520
Medical Device Problem Codes	Inappropriate Audible Prompt/Feedback (2280); Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that alarms cannot be acknowledged at the infinity central station.It was reported that the patient data was missing, and that the ves detection stopped working.It was noted that leads were switched to those with the most clearly deviating qrs morphology to see if it can detect and it reverts to the normal default setting and takes 18 min before it detects ves again.There are many ves in the meantime.There was no report of any adverse event or patient harm.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Additional Manufacturer Narrative
The customer reported that alarms could not be acknowledged, that patient data was missing, and that the ves detection stopped working.There was no report of any adverse event or patient harm.It was stated in the description of event that leads were switched to those with the most clearly deviating qrs morphology to see if it can detect and it reverts to the normal default setting and takes 18 min before it detects ves again.Several attempts were made to determine to clarify where the alarms could not be acknowledged and where data was missing, what system the customer is stating that the ves stopped working (iacs or ics), if logs of the date of event were available for analysis and what the resolution was to the stated issue however, this information was not made available.Due to the lack of information a root cause of the stated complaint is not known at this time.If more information should become available, a child record associated with this complaint will be opened for proper documentation.
Event or Problem Description
The customer reported that alarms cannot be acknowledged at the infinity central station.It was reported that the patient data was missing, and that the ves detection stopped working.It was noted that leads were switched to those with the most clearly deviating qrs morphology to see if it can detect and it reverts to the normal default setting and takes 18 min before it detects ves again.There are many ves in the meantime.There was no report of any adverse event or patient harm.

• Brand Name: INFINITY ACUTE CARE SYSTEM (M540)
• Common Device Name: PHYSIOLOGICAL MONITORING SYSTEMS
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA 18969
• Manufacturer Contact: 3135 quarry road; telford, PA 18969 ; 9784828529
• MDR Report Key: 19632789
• Report Number: 1220063-2024-00082
• Device Sequence Number: 20985099
• Product Code: MHX
• UDI-Device Identifier: 04049098009799
• UDI-Public: (01)04049098009799(11)221018(17)230116(93)MS25520-68
• Combination Product (Y/N): N
• PMA/510(K) Number: K113798
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2024

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 Catalogue Number: MS25520
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown