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

Catalog Number MS20401

Device Problem Failure to Analyze Signal (1539)

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

Event Date 11/22/2023

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 users observed signal artefacts on the arterial blood pressure curve during a surgery.The issue was intermittent and, it was reported that electrosurgical equipment was in use during the procedure.

Manufacturer Narrative

The customer reported arterial line interference during cautery.The issue was confirmed by a video provided by the customer during use.Additional information regarding on site systems, practices, and images was requested, but sufficient information was not provided.As not enough clinical information was provided - a root cause could not be determined.A draeger technician went onsite evaluated the device, and the error could not be reproduced.As by design, the filter esu settings only affect the ecg readings, and the arterial line may show interference when there are forceps attached to the patient.The customer was advised that interference could occur if esu or its cables are too close to the dual hemo transducer.Per clinical input, this is affected by the clinician's preference, how the or is set up, what kind of operation is taking place, where the cauterizing is occurring on the patient's body, etc.If either of the esu cables going to or from the patient are close to the transducer cable, it could cause interference.However, the customer did not provide any information regarding the esu location, or set up, clinical practice, etc, so the above statement cannot be confirmed or denied as the root cause.There are multiple warnings on keeping transducer cables away from esu cables in the instructions for use.(ifu) the customer was informed of the above information regarding esu and transducer locations during clinical use, and the customer did not respond to advise regarding the esu setting information or allege any reoccurrence of the malfunction.The draeger technician tested the mcable dual hemo with the iacs, and all devices passed manufacturers testing, and were returned to use.No further issues have been reported.H3 other text : see h10.

Event Description

It was reported that the users observed signal artifacts on the arterial blood pressure curve during a surgery.The issue was intermittent and, it was reported that electrosurgical equipment was in use during the procedure.

• 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: 18333534
• MDR Text Key: 330551300
• Report Number: 1220063-2023-00051
• Device Sequence Number: 1
• Product Code: MHX
• 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: 12/15/2023

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2023
• Initial Date FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: No
• 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