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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 Tachycardia (2132)
Event Date 07/21/2016
Event Type  malfunction  
Manufacturer Narrative
Onsite testing of the involved devices conducted by a spacelabs field service engineer confirmed a visual and audible alarm occurred with a simulated 11 beat run and a 5 beat run threshold.The equipment performed to specifications.The testing was witnessed by a hospital representative.Spacelabs has launched an investigation and will file a supplemental report once the investigation is complete.
 
Event Description
Spacelabs received a report that on (b)(6) 2016 at 2:59 p.M.A 28 beat run of ventricular tachycardia (vtach) did not alarm for vrun at the telemetry central station.No one was injured as a result of this event.
 
Manufacturer Narrative
The printout of the rhythm strip that was recorded during the event was reviewed by a spacelabs lead software engineer and verified that it satisfied the requirements for a run alarm.Based on the customer¿s statement that there was an alarm recording of the run alarm stored in the ics database and visible in clinical access, the monitor detected the episode, classified it as a run and generated an alarm.On site testing confirmed both visual and audible alarms, and that the device performs to specifications.There is no evidence of device malfunction.This report is considered final and the issue is closed.
 
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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
john zeng
35301 se center st.
snoqualmie, WA 98065
4253635915
MDR Report Key5902637
MDR Text Key53974152
Report Number3010157426-2016-00078
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 user facility
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 12/23/2016
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 Number90478
Other Device ID Number3.05.07
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/26/2016
Initial Date FDA Received08/24/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/23/2016
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 Number1
Patient Age63 YR
Patient Weight110
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