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

Catalog Number MS25510

Device Problem Insufficient Information (3190)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/26/2023

Event Type  Death  

Manufacturer Narrative

The investigation has just started, results will be provided in a follow-up report.

Event 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.

Manufacturer Narrative

The report has been submitted due to misunderstanding.It could later be confirmed that there has no reportable event occurred.

Event 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
• Type of Device: 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
• MDR Text Key: 327023554
• Report Number: 1220063-2023-00037
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04049098054409
• UDI-Public: (01)04049098054409(11)211105(17)211226(93)MS25510-67
• Combination Product (y/n): N
• PMA/PMN Number: K061379
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: MS25510
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2023
• Initial Date FDA Received: 11/01/2023
• Supplement Dates Manufacturer Received: 11/02/2023
• Supplement Dates FDA Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/31/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Death