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

Model Number MS20401

Device Problem No Audible Prompt/Feedback (2282)

Patient Problem Low Oxygen Saturation (2477)

Event Date 05/17/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the infinity acute care system (iacs) did not provide the expected high priority (red) alarm (red), it provided a medium priority (yellow) alarm on a neonatal patient in the neonatal intensive care unit (nicu).The spo2 was set to 90 and the patient went as low as 60.There was no patient injury.

Event Description

It was reported that the infinity acute care system (iacs) did not provide the expected high priority (red) alarm (red), it provided a medium priority (yellow) alarm on a neonatal patient in the neonatal intensive care unit (nicu).The spo2 was set to 90 and the patient went as low as 60.There was no patient injury.

Manufacturer Narrative

The concerned device was inspected by dräger on-site.It was found that the so-called "satseconds" function was enabled.The intention of this function is the suppression of nuisance alarms when thresholds are only exceeded briefly but frequently.The degree of suppression can be adjusted by the user.As per report, the user was expecting a high-priority desaturation alarm in the event situation.Base for this was the "desat alarm" function, a specific alarm behavior for monitoring of neonates which is enabled by default setting.This function increases the priority for a desaturation alarm from medium to high once the device detects a decrease of spo2 by 10% below the threshold.This function will however be disabled by activation of the satseconds alarm suppression feature; the ifu clearly refer in detail to that.Dräger finally concludes that there is no issue with the device which would require repair or correction.The observed behavior was related to the activation of a specific mode which disables another one.It is under responsibility and control of the user to adjust monitoring parameter to the specific needs of the individual patient and to verify appropriateness of changes after their execution.The dräger engineer explained his expertise to the staff and disabled the satseconds function after having agreed this with the users.Onsite support returned the iacs to satseconds off (default) which resolved the reported issue.This was a configuration/setting issue with no malfunction of the iacs and therefore this case has been closed.

• 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 ; 2156602400
• MDR Report Key: 17367685
• MDR Text Key: 320024758
• Report Number: 1220063-2023-00021
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04049098054454
• UDI-Public: (01)04049098054454(11)210519(91)N/A(93)MS20401-30
• Combination Product (y/n): N
• PMA/PMN Number: K203088
• 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,Followup
• Report Date: 09/29/2023

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 Model Number: MS20401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2023
• Initial Date FDA Received: 07/20/2023
• Supplement Dates Manufacturer Received: 09/12/2023
• Supplement Dates FDA Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2021
• 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