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 XHIBIT CENTRAL STATION; XHIBIT CENTRAL MONITOR
  • 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 XHIBIT CENTRAL STATION; XHIBIT CENTRAL MONITOR Back to Search Results
Model Number 96102
Device Problems Failure to Sense (1559); Electrical Power Problem (2925); Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/27/2020
Event Type  malfunction  
Manufacturer Narrative
A spacelabs confirmed the hard drive was corrupted caused by a failure of the system¿s external, 3rd party ups.Replacing hard drive resolved the issue with the central station.The unit passed all functional tests and was returned to customer.This report is complete, and this particular issue is considered closed.
 
Event Description
Customer reported that on (b)(6) 2020 the central stopped monitoring patients.Due to a power outage that corrupted the central hard drive.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SPACELABS XHIBIT CENTRAL STATION
Type of Device
XHIBIT CENTRAL MONITOR
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 Key10197870
MDR Text Key200618201
Report Number3010157426-2020-00007
Device Sequence Number1
Product Code MHX
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K122146
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Remedial Action Repair
Type of Report Initial
Report Date 01/01/2005,06/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number96102
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Date Report to Manufacturer01/10/2005
Initial Date Manufacturer Received 05/27/2020
Initial Date FDA Received06/25/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/09/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-