• 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 ULTRAVIEW SL COMMAND MODULE; ULTRAVIEW SL MULTIPARAMETER 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 ULTRAVIEW SL COMMAND MODULE; ULTRAVIEW SL MULTIPARAMETER MODULE Back to Search Results
Model Number 91496
Device Problem Device Alarm System (1012)
Patient Problem Ventricular Tachycardia (2132)
Event Date 07/12/2016
Event Type  malfunction  
Manufacturer Narrative
The customer¿s biomed tested the module and could not reproduce the symptom.The biomed is sending the module to spacelabs for additional testing.Spacelabs has attempted to collect historical waveforms and trend data from the ics database, but due to the amount of time from the date of occurrence to when the customer reported the issue, the data had already been purged.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 approximately 4:00 am, a run of ventricular tachycardia (vtach) did not alarm for vrun at bedside or central monitor.No one was injured as a result of this event.
 
Manufacturer Narrative
The customer biomed tested the involved devices and could not reproduce the symptom.A spacelabs field service engineer went on-site and confirmed that all tests passed.The customer opted to send the nine year old device to spacelabs depot repair for further evaluation.The patient's historical waveforms and trend information were no longer available because the data had been purged.Spacelabs service center received the device and the cpu board was replaced, however no correlation could be made between the replaced part and the reported event.The repaired unit passed all functional tests and was restored to service.This report is considered final and the issue is closed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SPACELABS ULTRAVIEW SL COMMAND MODULE
Type of Device
ULTRAVIEW SL MULTIPARAMETER 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 Key5918253
MDR Text Key54295909
Report Number3010157426-2016-00086
Device Sequence Number1
Product Code DSI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103142
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Biomedical Engineer
Remedial Action Repair
Type of Report Initial,Followup
Report Date 01/11/2017
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 Number91496
Other Device ID Number2.04.03
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/02/2016
Initial Date FDA Received08/31/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/11/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-