MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA VISTA 120; PHYSIOLOGICAL MONITORING SYSTEMS

Catalog Number MS31996

Device Problem False Device Output (1226)

Patient Problem Therapeutic Response, Increased (2272)

Event Date 03/09/2018

Event Type  Injury  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow up-report.

Event Description

It was reported that the monitor displayed a heart rate that was twice as high as the actual value.The users decided to apply drugs in order to handle the situation.

Event Description

Please refer to the initial report.

Manufacturer Narrative

The videos provided by the complainant have been analyzed.The calculation of a too high heart rate as described occurred under very specific circumstances: the qrs wave was very narrow, positive and negative bi-directional with amplitude around 1mv while at the same time, the t wave was also very tall with amplitude more than half of that of the qrs wave.For lead i and iii, no false high calculation of the heart rate occurred where the t wave was either smoother or smaller - the reported condition was only occurring when lead ii was in use.The algorithm used by the device was derived from an open document of tompkins "a real-time qrs detection algorithm".In terms of tall t-wave rejection, the device complies with iec 60601-2-27: 2011, sect.201.12.1.101.17.Special situations are imaginable which can be very challenging for the algorithm.To assist the user in recognizing such conditions the ifu provides the following information under "selecting calculation lead": the normal qrs should be either completely above or below the baseline and it should not be biphasic.For paced patients, the qrs complexes should be at least twice the height of pace pulses.The qrs should be tall and narrow.The p-waves and the t-waves should be less than 0.2 mv.In situations where the t-waves are much higher and double-counting is likely to occur, alternative calculation leads should be checked or pulse rate of spo2-monitoring could be used instead.As a consideration in general cannot be excluded that a patient gets a false therapy if clinical decisions are made based on the readings of one single vital parameter.To emphasize the importance of double-checking other clinical signs before intervention is initiated the ifu contains the following warning: "risk of misinterpretation: misdiagnosis or misinterpretation of the measured values or other parameters can endanger the patient.Do not make therapeutic decisions based solely on individual measured values and monitoring parameters.Therapeutic decisions must be made solely by qualified users." dräger finally concludes that the event occurred due to a special patient condition that would have required critical check of lead selection.The unnecessary application of medication could have been avoided if a plausibility check via other vital parameter had been provided or a different lead had been used for verification.The ifu refers to the associated risks of disregarding that; furthermore can be considered that the aforementioned aspects are basic knowledge for personnel in critical care.

• Brand Name: VISTA 120
• Type of Device: PHYSIOLOGICAL MONITORING SYSTEMS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 7360891
• MDR Text Key: 103136523
• Report Number: 9611500-2018-00073
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K053484
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Device Catalogue Number: MS31996
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1