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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 Defective Alarm (1014)
Patient Problem No Information (3190)
Event Date 10/05/2016
Event Type  malfunction  
Manufacturer Narrative
Onsite investigation of the involved devices was not possible as the devices remained in use. The patient¿s arrhythmia review strips as well as the retrospective database provided by the facility was reviewed by a spacelabs lead software engineer. The retrospective database shows a medium priority alarm for tachycardia that generated an audible and visual alarm; the rhythm was classified as supraventricular. Due to a database corruption issue, there is insufficient information available to determine the reason for the non-ventricular classification. According to the operations manual, some beats may not be recognized as being morphologically different from the learned dominant beat. There have been no reports of recurrence. The investigation is considered complete and the issue closed.
 
Event Description
Spacelabs received a report that on (b)(6) 2016, an episode of ventricular tachycardia (vtach) did not alarm at the central monitor. No one was injured as a result of this event.
 
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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
marc rivas
35301 se center st.
snoqualmie, WA 98065
4253635568
MDR Report Key6079618
MDR Text Key59507510
Report Number3010157426-2016-00173
Device Sequence Number1
Product Code DSI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K983996
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 11/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number90478
Other Device ID Number3.05.07
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/06/2016
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 Treatment Data
Date Received: 11/04/2016 Patient Sequence Number: 1
Treatment
(B)(4)
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