Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 RECEIVER MODULE
  • 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 RECEIVER MODULE Back to Search Results
Model Number 90478
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/09/2020
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
Spacelabs received that on (b)(6) 2020 a patient incident occurred for a uvsl telemetry patient.
 
Manufacturer Narrative
No adverse event reported.After several attempts at getting additional information from customer.Field service engineer confirmed, no alleged malfunction occur.Patient was released from continued care in (b)(6) 2019, customer was inquiring about historical data from (b)(6) 2019.This report is complete, and this particular issue is considered closed.H3 other text: placeholder.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
MDR Report Key10659452
MDR Text Key212763315
Report Number3010157426-2020-00040
Device Sequence Number1
Product Code DSI
Combination Product (y/n)Y
PMA/PMN Number
K983996
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 01/01/2005,01/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number90478
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Date Report to Manufacturer01/10/2005
Date Manufacturer Received09/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-