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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPACELABS HEALTHCARE LTD. UNIVERSAL CUFF COVER STANDARD SIZE BLOOD PRESSURE CUFF COVER

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SPACELABS HEALTHCARE LTD. UNIVERSAL CUFF COVER STANDARD SIZE BLOOD PRESSURE CUFF COVER Back to Search Results
Catalog Number 706-0182-00
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Reaction (2414)
Event Date 12/17/2019
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 patient who has been fitted this week in the metabolic unit, wgh with a 24 hour spacelabs abpm with the blue universal cuff cover has had an allergic reaction.
 
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Brand NameUNIVERSAL CUFF COVER STANDARD SIZE
Type of DeviceBLOOD PRESSURE CUFF COVER
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 Key9602758
MDR Text Key196057242
Report Number9611295-2020-00001
Device Sequence Number1
Product Code DXN
Combination Product (y/n)Y
Reporter Country CodeUK
PMA/PMN Number
K141113
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/01/2005,04/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number706-0182-00
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
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 Received12/17/2019
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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