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U.S. Department of Health and Human Services

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

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SPACELABS HEALTHCARE INC. SPACELABS TELEMETRY RECEIVER MODULE Back to Search Results
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.

 
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Brand NameSPACELABS TELEMETRY RECEIVER MODULE
Type of DeviceTELEMETRY 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 Key5429638
MDR Text Key38104740
Report Number3010157426-2016-00014
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK925510
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/17/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/10/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number90478
OTHER Device ID Number3.05.08
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2016
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

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