• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. SPACELABS TELEMETRY RECIEVER HOUSING TELEMETRY HOUSING

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SPACELABS HEALTHCARE INC. SPACELABS TELEMETRY RECIEVER HOUSING TELEMETRY HOUSING Back to Search Results
Model Number 90479
Device Problem Telemetry Discrepancy (1629)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/08/2018
Event Type  Malfunction  
Manufacturer Narrative

Spacelabs¿ technical support provided instruction for troubleshooting this (b)(4)-year old telemetry system. The customer¿s biomed resolved this issue without further assistance from spacelabs. This report is complete and this particular issue is considered closed.

 
Event Description

Spacelabs received a report on (b)(6) 2018 of loss of monitoring telemetry patients from an ultraview telemetry receiver. No injury was reported with this event.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSPACELABS TELEMETRY RECIEVER HOUSING
Type of DeviceTELEMETRY HOUSING
Manufacturer (Section D)
SPACELABS HEALTHCARE INC.
35301 se center st.
snoqualmie WA 98065
Manufacturer Contact
david geraghty
35301 se center st.
snoqualmie, WA 98065
4253635889
MDR Report Key8087773
MDR Text Key128600331
Report Number3010157426-2018-00102
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)Y
Reporter Country CodeUS
PMA/PMN NumberK925510
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial
Report Date 01/01/2005,10/01/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/19/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number90479
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 Received09/08/2018
Is this a Reprocessed and Reused Single-Use Device? No

-
-