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

Model Number	MS18500
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital biomed reported that smoke was coming from the infinity centralstation (ics).Upon further investigation he found that the dvd drive cable had been melted.He indicated he disconnected the dvd cable from power supply.But still has the ics in use.There was no indication of fire reported.No adverse patient impact was reported.On (b)(6) 2023 the hospital biomed later reported that the cable itself burnt to a crisp.He removed the dvd player and booted the system back up.If the system ever needs a software reload, then i guess i will need a new dvd, player and cable both were burnt up pretty bad.This is the 3rd ics i have seen in the last 15 years catch fire at that cable connector.
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of this investigation.
Event or Problem Description
The hospital biomed reported that smoke was coming from the infinity central station (ics).Upon further investigation he found that the dvd drive cable had been melted.He indicated he disconnected the dvd cable from power supply.But still has the ics in use.There was no indication of fire reported.No adverse patient impact was reported.On (b)(6) 2023 the hospital biomed later reported that the cable itself burnt to a crisp.He removed the dvd player and booted the system back up.If the system ever needs a software reload, then i guess i will need a new dvd, player and cable both were burnt up pretty bad.This is the 3rd ics i have seen in the last 15 years catch fire at that cable connector.
Additional Manufacturer Narrative
The issue points to a known deficiency of the dvd drive cable.Draeger is aware of similar events with the cable and informed the user community about the necessity to replace the cable; replacement cables were provided as well by draeger.The records maintained at dräger indicate that a new cable was shipped to the customer in 04/2022.The customer responded in 10/2022 to have performed the replacement.It is not known why an issue with the dvd cable has occurred in 05/2023; the user did not respond to related questions; the involved cable was also not returned.Finally, the investigation remains inconclusive.Dräger is not aware of any other incidents in which the improved cable version had failed; it cannot be excluded that the product was still equipped with the old cable at the time of this particular incident.

• Brand Name: 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 ; 2156602400
• MDR Report Key: 17399547
• Report Number: 1220063-2023-00023
• Device Sequence Number: 12245185
• Product Code: MHX
• UDI-Device Identifier: 04049098004190
• UDI-Public: (01)04049098004190(11)110330(21)11516M00300(93)MS18500-27
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2024

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: MS18500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2023
• Supplement Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2011
• 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