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

Model Number 90478

Device Problem Device Alarm System (1012)

Patient Problem Ventricular Fibrillation (2130)

Event Date 01/22/2016

Event Type  malfunction  

Manufacturer Narrative

An onsite investigation of the involved devices performed by a spacelabs field service engineer confirmed that the involved devices worked to specifications.Spacelabs has launched an investigation into this event and will file a supplemental report when the investigation is complete.

Event Description

Spacelabs received a report that on (b)(6) 2016 at 3:19 a.M.No alarm was generated for a 12 beat run of vtach (ventricular tachycardia) from a patient monitored with telemetry transmitter model 91343, telemetry receiver module model 90478 and telemetry central monitor model 91387-38.There was no report of injury for this event.

Manufacturer Narrative

The patient's historical waveforms and trend information were reviewed by a spacelabs lead software engineer.The historical waveforms show a 15 beat run of ventricular tachycardia at 3:18:35am on (b)(6) 2016, and it was confirmed that all of the beats in the episode were accurately detected.The investigation findings show that some beats were recognized as learned dominant beats, therefore the episode did not meet the criteria to generate a run alarm.The device performed to specifications.This report is considered final and the issue is closed.

• 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: daniel herrera ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635631
• MDR Report Key: 5429638
• MDR Text Key: 38104740
• Report Number: 3010157426-2016-00014
• 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: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2016
• 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: 3.05.08
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2016
• 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 Age: 72 YR