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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC PHILIPS ST80I STRESS TEST SYSTEM

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PHILIPS NORTH AMERICA LLC PHILIPS ST80I STRESS TEST SYSTEM Back to Search Results
Model Number 860343
Device Problem Inadequate User Interface (2958)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/30/2021
Event Type  malfunction  
Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
 
Event Description
Customer reported the emergency stop button is not working. The device was in use on a patient. There was no report of patient or user harm.
 
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Brand NamePHILIPS ST80I STRESS TEST SYSTEM
Type of DevicePHILIPS ST80I STRESS TEST SYSTEM
Manufacturer (Section D)
PHILIPS NORTH AMERICA LLC
3000 minuteman road
andover MA 01810
Manufacturer (Section G)
PHILIPS NORTH AMERICA LLC
3000 minuteman road
andover MA 01810
Manufacturer Contact
derek sammarco
222 jacobs st
cambridge, MA 02141
6172455900
MDR Report Key11872475
MDR Text Key252249678
Report Number1218950-2021-10588
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121638
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number860343
Device Catalogue Number860343
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date04/30/2021
Event Location No Information
Date Manufacturer Received04/30/2021
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

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