MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY DOCKING STATION; COMPUTER INTERFACE

Catalog Number MS18597

Device Problem Failure to Sense (1559)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/15/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing; results will be provided in a follow-up report.H3 other text : on-going.

Event Description

It was reported that the patient monitor lost the co2 trace during an anesthetic procedure and was alarming for battery error.The delta patient monitor was connected via an infinity docking station (ids) to a dräger fabius anesthesia workstation; the gas readings were provided by a dräger scio anesthetic gas monitor.It was mentioned in the report that the event did not lead to consequences for the patient.

• Brand Name: INFINITY DOCKING STATION
• Type of Device: COMPUTER INTERFACE
• 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 ; 9784470587
• MDR Report Key: 18401266
• MDR Text Key: 331733307
• Report Number: 1220063-2023-00054
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04049098004152
• UDI-Public: (01)04049098004152(11)190329(93)MS18597-66
• Combination Product (y/n): N
• PMA/PMN Number: K050974
• 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
• Report Date: 12/27/2023

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: MS18597
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2023
• Initial Date FDA Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: No
• 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