MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY ACUTE CARE SYSTEM (M540); PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT

Catalog Number MS25520

Device Problem Intermittent Communication Failure (4038)

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

Event Date 10/09/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the cockpit of the patient monitoring system performed a reboot during use.The bedplace monitor continued to monitor the patient.No patient consequences were resulting form the event.

• Brand Name: INFINITY ACUTE CARE SYSTEM (M540)
• Type of Device: PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT
• 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 ; 9783798000
• MDR Report Key: 18090476
• MDR Text Key: 327597085
• Report Number: 1220063-2023-00040
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04049098009799
• UDI-Public: (01)04049098009799(11)180919(17)190107(93)MS25520-51
• Combination Product (y/n): N
• PMA/PMN Number: K113798
• 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: 11/08/2023

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: MS25520
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2023
• Initial Date FDA Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/19/2018
• 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