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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPACELABS HEALTHCARE LTD. SYSTEM CARDIOLOGY INFORMATION SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMABLE

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SPACELABS HEALTHCARE LTD. SYSTEM CARDIOLOGY INFORMATION SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMABLE Back to Search Results
Model Number 98200
Device Problems Computer Software Problem (1112); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/21/2020
Event Type  malfunction  
Manufacturer Narrative
Spacelabs has initiated an investigation into this matter. A supplemental report will be filed once the investigation is complete.
 
Event Description
A hospital has voiced concern that when upgrading from v9 to v11, all the 12 leads tests on which the costumer had previously deleted the automatic interpretation (coming from cardioexpress devices and/or cd12 usb) were again populated with the glasgow interpretation. This has caused some issues due to incorrect interpretations which were thought to be from a physician. No injury to patient reported.
 
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Brand NameSYSTEM CARDIOLOGY INFORMATION SYSTEM
Type of DeviceCOMPUTER, DIAGNOSTIC, PROGRAMABLE
Manufacturer (Section D)
SPACELABS HEALTHCARE LTD.
unit b, foxholes centre
john tate road
hertford SG137 DT
UK SG137DT
Manufacturer Contact
marc rivas
35301 se center st.
snoqualmie, WA 98065
4253635568
MDR Report Key10766480
MDR Text Key249619810
Report Number9611295-2020-00003
Device Sequence Number1
Product Code DQK
Combination Product (y/n)Y
Reporter Country CodePO
PMA/PMN Number
K152881
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date 01/01/2005,02/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number98200
Device Catalogue Number98200
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report to Manufacturer01/10/2005
Date Manufacturer Received09/21/2020
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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