MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC DELTA; PHYSIOLOGIC MONITORING SYSTEM

Catalog Number MS18597

Device Problem Inaudible or Unclear Audible Prompt/Feedback (2283)

Patient Problem Asystole (4442)

Event Date 03/21/2024

Event Type  malfunction  

Event Description

The customer reported that there was no alarm heard for an asystole on a delta device.No additional information regarding the event was provided.There was no report of patient injury or death.

Manufacturer Narrative

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

• Brand Name: DELTA
• 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: 19144921
• MDR Text Key: 340612918
• Report Number: 1220063-2024-00046
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04049098004152
• UDI-Public: (01)04049098004152(11)220104(93)MS18597-73
• Combination Product (y/n): N
• PMA/PMN Number: K152407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other