MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC ICS INFINITY CENTRAL STATION; PHYSIOLOGICAL MONITORING SYSTEMS

Catalog Number	MS32504
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.H3 other text : ongoing.
Event or Problem Description
It was reported to draeger that cable of the computer mouse used in connection with the central monitor station ics exhibited a short circuit and was sparking.The event did not lead to health consequences for any person.
Event or Problem Description
It was reported to draeger that cable of the computer mouse used in connection with the central monitor station ics exhibited a short circuit and was sparking.The event did not lead to health consequences for any person.
Additional Manufacturer Narrative
A complaint was submitted where it was reported that an ics mouse in use had a frayed cable and was reportedly spraying sparks.The pictures provided of the frayed mouse cable show the device was so badly damaged that the wires were exposed and burn marks were seen.The exposed wires were touching each other as well.When the wires are frayed in this manner an electrical short occurs and causes the sparks that were reported.The root cause of the reported issue is due to the damaged mouse cable.All usb ports have thermally activated self resetting fuses to protect against excessive current draw that limits the possibility of an external fire.The usb port will turn off and report an over current condition to the operating system.Users are advised to inspect all equipment before use and never put damaged equipment into service.This damaged ics seal shield mouse should be replaced immediately.Information regarding the details of the reported event were requested several times but were not provided.This information is critical in determining the specifics surrounding the reported issue and needed to further contribute to this investigation.This complaint is being closed and if in the future further relevant information is provided, a new complaint will be opened to investigate the information.It was confirmed that there was no patient injury due to the reported event.

• Brand Name: ICS INFINITY CENTRAL STATION
• 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
• Manufacturer Contact: 3135 quarry road; telford, PA ; 9784470587
• MDR Report Key: 18552587
• Report Number: 1220063-2024-00008
• Device Sequence Number: 7597549
• Product Code: MHX
• UDI-Device Identifier: 04049098001878
• UDI-Public: (01)04049098001878(11)211102(93)MS26800-47
• Combination Product (Y/N): N
• PMA/510(K) Number: K061379
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 05/08/2024

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: MS32504
• 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: 01/08/2024
• Supplement Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 01/22/2024
• Supplement Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown