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

Catalog Number MS20401

Device Problems Human-Device Interface Problem (2949); Patient Data Problem (3197)

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

Event Date 09/26/2023

Event Type  malfunction  

Event Description

The customer reported that when nibp intervals are used, they are seeing duplicate measurements in the patient data management system.

Manufacturer Narrative

The investigation is ongoing; results will be provided in a follow-up report.

Manufacturer Narrative

It was reported when nibp (non-invasive blood pressure) intervals are used, duplicate measurements are displayed in the data collection system.When an iacs is set to monitor periodic nibp on a q5 interval where it sends a message the first minute via the infinity gateway to the customer¿s emr (electronic medical record).5 minutes later, the next measurement should display but, in this case, the previous reading is displaying.After the duplicate (previous reading) is displayed, the new measurement displays the following minute.Due to variations in the timestamps coming from the monitor, this does not get flagged by the gateway server¿s ¿filter repeat data¿ setting to be filtered out as a duplicate.Messaging history for that monitor continuously has a duplicate, followed by a new measurement a minute later in the patient¿s flowsheet.An escalation case was opened to further investigate the reported issue where it was concluded this was a software bug in both versions vg4.2 and vg7.Without logic to remove the duplicate reading at the set interval time, it creates false entries in the emr.The current system does not possess the appropriate tools to resolve which is why it would be preferable for a change to be made on a real integration engine, but the customer may not have that available.In software like rhapsody or corepoint you can store values as variables and perform calculations with them.In this case the best fix subtracts the two values of the previous measured time and the one in the current message, and if they¿re within a certain range, discards one of them.The reason this bypasses the ¿filter repeat data¿ setting on the gateway is that the resending message has a slightly different timestamp due to a clock issue.The source of the issue resides in the iacs internal clock which causes the duplicate nibp message.There is a different clock mechanism or behavior in the vg8 iacs.It has been confirmed this issue is not reproduceable in software version vg8.Escalation confirmed they will be in regular contact with the customer to stay up to date with the issue as well as the release of iacs vg8.Originally reported under the incorrect mdr number: 9611500-2023-00466.

Event Description

The customer reported that when nibp intervals are used, they are seeing duplicate measurements in the patient data management system.

• 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: 18316374
• MDR Text Key: 330355860
• Report Number: 9611500-2023-00466
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04049098054454
• UDI-Public: (01)04049098054454(11)230124(17)231130(93)MS20401-32
• 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,Followup
• Report Date: 12/13/2023

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: MS20401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 11/13/2023
• Supplement Dates FDA Received: 05/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2023
• 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