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

Catalog Number MS18501

Device Problem No Device Output (1435)

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

Event Date 03/15/2024

Event Type  malfunction  

Event Description

The customer reported that there was no alarm at the ics when an ecg or spo2 cable is disconnected from the m300.The user at the central will potentially will not know that the patient is no longer being monitored which has the potential for adverse patient impact.No injury or other patient impact was reported.

Manufacturer Narrative

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

• 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 ; 9784828529
• MDR Report Key: 19037547
• MDR Text Key: 339300967
• Report Number: 1220063-2024-00038
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04049098004183
• UDI-Public: (01)04049098004183(11)161118(93)MS18501-35
• Combination Product (y/n): N
• PMA/PMN Number: K151860
• 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
• Report Date: 04/03/2024

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: MS18501
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2016
• 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