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

Catalog Number	MS25510
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
The investigation has just started, results will be provided in a follow-up report.
Event or Problem Description
It was reported that a patient died and, a review and analysis of patient trend data and alarm history was requested.There was no allegation of a device malfunction but since the investigation has just started; at this time, we cannot rule out that the dräger medical device mentioned was a factor in the patient¿s death.
Additional Manufacturer Narrative
The report has been submitted due to misunderstanding.It could later be confirmed that there has no reportable event occurred.
Event or Problem Description
We would like to inform you herewith that the initial report for 1220063-2023-00037 was sent by mistake.There was a misunderstanding of the initial information the manufacturer received from the local s&s organization.In fact, there was no patient death associated to the event - the customer did not allege a device malfunction and just wanted to have a log file analysis.After clarifying that, the case was assessed as not reportable.Please consider the initial report as unfounded.

• Brand Name: ICS INFINITY CENTRAL STATION
• Common Device Name: PHYSIOLOGIC MONITORING SYSTEM
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC.; 3135 quarry road; telford PA
• Manufacturer Contact: 3135 quarry road; telford, PA ; 9783798000
• MDR Report Key: 18046193
• Report Number: 1220063-2023-00037
• Device Sequence Number: 8255081
• Product Code: MHX
• UDI-Device Identifier: 04049098054409
• UDI-Public: (01)04049098054409(11)211105(17)211226(93)MS25510-67
• 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): 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MS25510
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/04/2023
• Supplement Date Received by Manufacturer: 11/02/2023
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2021
• 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; Death
• Patient Sex: Unknown