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

Model Number MS20401

Device Problems Self-Activation or Keying (1557); Failure to Read Input Signal (1581)

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

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted upon completion of this investigation.

Event Description

It was reported that the m540 switches to standby mode when on a patient.No adverse patient impact was reported.When the m540 is in standby mode, all patient monitoring/alarming is suppressed, all patient data displayed is replaced with a ¿standby, touch screen to resume monitoring¿ message.If a device switches to standby mode on its own, the user may not be aware that the device is in standby mode which could result in missed patient alarms/a delay in treatment.

Manufacturer Narrative

Additional information was provided.Noting, that no device logs were available.The device was tested by draeger.And the reported issue could not be reproduced.Therefore, the reported issue could not be verified.And root cause could not be determined.The end cap and front housing were replaced, due to damage noted, during evaluation.The device was returned to the customer.No further issues have been reported.H3 other text: a draeger technician, evaluated the device.And could not recreate the reported issue.

Event Description

It was reported, that the m540 switches to standby mode, when on a patient.No adverse patient impact was reported.When the m540 is in standby mode, all patient monitoring/alarming is suppressed.All patient data displayed is replaced with a ¿standby, touch screen to resume monitoring¿ message.If a device switches to standby mode on its own, the user may not be aware that the device is in standby mode.Which could result, in missed patient alarms/a delay in treatment.

• Brand Name: INFINITY ACUTE CARE SYSTEM (M540)
• Type of Device: PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 6 tech drive; andover MA
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC; 6 tech drive; andover MA
• MDR Report Key: 14860602
• MDR Text Key: 302001585
• Report Number: 1220063-2022-00009
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04049098054454
• UDI-Public: 04049098054454
• Combination Product (y/n): N
• PMA/PMN Number: K113798
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MS20401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2015
• 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