MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC M300; PHYSIOLOGIC MONITORING SYSTEM

Catalog Number MS25755

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Arrest (1762)

Event Date 12/18/2023

Event Type  Death  

Manufacturer Narrative

The evaluation has just started; results will be provided in a follow-up report.H3 other text : ongoing.

Event Description

It was reported that a patient was monitored with a telemetry device; the heart rate displayed at the central monitoring station (cms) was 86bpm.A nurse was with the patient until 9:10 pm.The patient had a heart attack within the next few minutes; the bed neighbor called the nurse at 9:14.Unfortunately, the initiated resuscitation efforts were not successful, the patient died.

• Brand Name: M300
• 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 ; 9784470587
• MDR Report Key: 18397123
• MDR Text Key: 331362516
• Report Number: 1220063-2023-00056
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04049098048989
• UDI-Public: (01)04049098048989(11)210405(91)VG2.3.1(93)MS25755-30
• Combination Product (y/n): N
• PMA/PMN Number: K151860
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MS25755
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2023
• 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
• Patient Outcome(s): Death