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

Catalog Number MS26800

Device Problem No Visual Prompts/Feedback (4021)

Patient Problem Tachycardia (2095)

Event Date 03/05/2024

Event Type  malfunction  

Event Description

The customer reported that the infinity central station failed to alarm for ventricular tachycardia on (b)(6) and (b)(6).There was no report of patient injury or patient death.

Manufacturer Narrative

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

• Brand Name: INFINITY CENTRAL STATION
• Type of Device: 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
• Manufacturer Contact: 3135 quarry road; telford, PA ; 9784828529
• MDR Report Key: 19153155
• MDR Text Key: 341182364
• Report Number: 1220063-2024-00045
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04049098001878
• UDI-Public: (01)04049098001878(11)141001(93)MS26800-12
• Combination Product (y/n): N
• PMA/PMN Number: K061379
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/22/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: MS26800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2024
• 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