MAUDE Adverse Event Report: INVIVO CORPORATION XPER FLEX CARDIO PHYSIOMONITORING SYSTEM; CARDIOVASCULAR MONITOR

Model Number 453564243601

Device Problem Device Alarm System (1012)

Patient Problems Ventricular Tachycardia (2132); Therapeutic Response, Decreased (2271)

Event Date 06/04/2015

Event Type  Injury  

Event Description

The customer reported a patient went into vt and alleged the device ¿failed¿ in that the customer was "used to" the alarm that was sounding and it did not draw their attention to the patients¿ condition.The customer claimed that, as a result, treatment of the patient was delayed.The device was in clinical use to monitor the patient at the time the issue was discovered.The patient went into ventricular tachycardia which required acls (advanced cardiac life support) and cpr (cardiopulmonary resuscitation).The patient was subsequently reported as "stable, post pci, the patient regained a stable rhythm and was sent to icu".

Manufacturer Narrative

The patient went into ventricular tachycardia which required acls (advanced cardiac life support) and cpr (cardiopulmonary resuscitation).Therefore, we are considering this to be a serious injury.Data from the device retrieved by the philips remote support engineer found that the device functioned properly in this case.However, the customer claimed that the device ¿failed¿ in that the customer was "used to" the alarm that was sounding and it did not draw their attention to the patient¿s condition.The customer claimed that, as a result, treatment of the patient was delayed.A follow up report will be submitted once the investigation is complete.

Manufacturer Narrative

This investigation concludes that no device malfunction or deficiency occurred on a philips device, the device is functioning as intended, and therefore this is not considered to be a valid failure.Data from the device retrieved by the philips remote support engineer at the customer care solution center found that the device functioned as intended in this case.The philips remote support engineer assisted the customer to verify the alarms were set up correctly and the pc volume was turned up adequately.The device did not behave as expected by the customer and the available information supports a user misunderstanding.We are considering that the delay in treatment of the patient was caused by user error since it was determined that the device performed and alarmed as designed and expected.The xper flex cardio physio monitoring instructions for use (ifu) 453564527561 release 3.1, 2014, "intended use and contraindications", section 1.1.1 states in part, "use of the system is not intended where unattended patient monitoring is desired, or in situations where arrhythmia detection is required".2.4 "specific safety information" states:¿ 2.4.17 heart rate determination: the xper flex cardio physio monitoring system utilizes an adaptive peak detector methodology to calculate heart rate.The system does not distinguish between normal and ectopic beats and may include both in determining a patients¿ heart rate.This may result in erroneous heart rate readings.Reported values should be verified by a qualified health care professional.Failure to comply may result in patient injury or misdiagnosis.2.4.18 arrhythmia detection: the xper flex cardio physio monitoring system does not have arrhythmia detection capability.An ecg monitor should be attached for patients in need of arrhythmia detection." we are considering the customers¿ request for ¿different alarms¿ to signify life threatening dysrhythmia to be an enhancement request.No products were replaced or returned to philips.The device remains at the customer site.No further action or investigation is warranted as the device was functioning as intended and the labeling of the device has been reviewed and determined to be clear and adequate.

• Brand Name: XPER FLEX CARDIO PHYSIOMONITORING SYSTEM
• Type of Device: CARDIOVASCULAR MONITOR
• Manufacturer (Section D): INVIVO CORPORATION; 12151 research parkway; suite 200; orlando FL 32826
• Manufacturer Contact: wendy chadbourne ; 12151 research parkway; suite 200; orlando, FL 32826
• MDR Report Key: 4844668
• MDR Text Key: 5940300
• Report Number: 1051786-2015-00008
• Device Sequence Number: 1
• Product Code: MWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 453564243601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/04/2015
• Initial Date FDA Received: 06/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2014
• 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): Required Intervention