MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. SPACELABS TELEMETRY RECEIVER MODULE

Model Number 90478

Device Problem Device Alarm System (1012)

Patient Problem Ventricular Tachycardia (2132)

Event Date 01/07/2016

Event Type  malfunction  

Manufacturer Narrative

Onsite investigation of the involved devices conducted by a spacelabs field service engineer confirmed that the equipment performed to specifications.The investigation was witnessed by a facility representative.The patient retrospective database provided by the facility was reviewed by a spacelabs lead software engineer.The database confirmed the presence of a 10 beat run of vtach at the reported event time that was not associated with an alarm.The ecg waveforms were extracted from the ics database and the embedded qrs tone markers were examined to determine which qrs complexes were detected.The monitored leads are ii and i, despite lead i having qrs amplitude of less than 0.2 mv which is below optimal level.The qrs tone markers indicated that the 7th beat of the run was not detected, but the first 6 beats would have generated an alarm if they had been classified as abnormal.The very small ecg amplitude in lead i may have contributed to the qrs classifications of some of the beats as dominant (normal) instead of abnormal preventing alarm thresholds from being met.The monitor did not generate a vtach run alarm due to misclassification of one or more of the detected beats.The performance of the 90478 telemetry receiver module ecg algorithm as documented in the 510k submission is a sensitivity of 95.00% in detection of ventricular beats.In this case, the qrs morphology of the ventricular beats resulted in some of the beats being misclassified as dominant (normal) beats.This investigation is considered complete and the issue closed.

Event Description

Spacelabs received a report that on (b)(6) 2016 at 12:53 a.M.A patient monitored with telemetry transmitter model 91343, telemetry receiver module model 90478, and central monitor model 91387-38 experienced a vtach (ventricular tachycardia) episode that did not generate an alarm.No one was injured as a result of this event.

• Brand Name: SPACELABS TELEMETRY RECEIVER MODULE
• Type of Device: TELEMETRY RECEIVER MODULE
• Manufacturer (Section D): SPACELABS HEALTHCARE INC.; 35301 se center st.; snoqualmie WA 98065
• Manufacturer Contact: marc rivas ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635568
• MDR Report Key: 5414597
• MDR Text Key: 38100867
• Report Number: 3010157426-2016-00011
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/05/2016

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: 90478
• Other Device ID Number: V3.05.08EN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2016
• Initial Date FDA Received: 02/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Weight: 87