MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY CENTRAL STATION; PHYSIOLOGIC MONITORING SYSTEM

Catalog Number	MS32504
Medical Device Problem Codes	Electrical Shorting (2926); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has started but is not yet concluded.We cannot exclude that the investigation alters the device or a sample of the batch concerned in a way which may affect any subsequent evaluation of the causes of the incident.
Event or Problem Description
The customer reported that the keyboard connection cable was "scorched" near where the cable meets the keyboard.The pictures provided confirmed the damage to the keyboard cable.It was reported that no entry could be made on the keyboard right before the damage to the cable was noticed.It was also confirmed there was no injury to the user or a patient and no impact on any other function of ics monitoring.There was no adverse patient or user impact or death reported.
Additional Manufacturer Narrative
The root cause of the reported issue is due to the damaged usb keyboard cable where the exposed wires were electrically shorted.Based on the pictures provided, the usb cable is twisted where it is hardwired into the keyboard.All usb ports on the workstation 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.All draeger products in use are designed to meet the iec 60601-1 standard for basic safety and essential performance of medical electrical equipment and the risk of fire is minimized because the used materials are classified as ul 94 v-0 or better.The instructions for use (ifu) provides the following caution notice: even accessories designed to be reused have a limited maximum period of use.Handling and reprocessing can increase wear and markedly shorten maximum period of use (e.G., disinfectant residues can attack the material more intensely during autoclaving).If signs of wear become visible, such as cracks, deformation, discoloration, peeling, etc., affected accessories must be replaced.Our service records show the customer was provided a new replacement keyboard (ms2287).No further issues have been reported, and no additional information was made available.
Event or Problem Description
The customer reported that the keyboard connection cable was "scorched" near where the cable meets the keyboard.The pictures provided confirmed the damage to the keyboard cable.It was reported that no entry could be made on the keyboard right before the damage to the cable was noticed.It was also confirmed there was no injury to the user or a patient and no impact on any other function of ics monitoring.There was no adverse patient or user impact or death reported.

• Brand Name: INFINITY CENTRAL STATION
• Common Device Name: PHYSIOLOGIC MONITORING SYSTEM
• 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 ; 9784097390
• MDR Report Key: 20225077
• Report Number: 1220063-2024-00108
• Device Sequence Number: 7418616
• Product Code: MHX
• UDI-Device Identifier: 04049098054447
• UDI-Public: (01)04049098054447(11)210301(91)MS32504-11
• Combination Product (Y/N): N
• PMA/510(K) Number: K061379
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2024
• Supplement Date Received by Manufacturer: 09/02/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/22/2021
• 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
• Patient Sex: Unknown