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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS ST8OI STRESS TEST SYSTEM; PHILIPS ST8OI STRESS TEST SYSTEM
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PHILIPS MEDICAL SYSTEMS ST8OI STRESS TEST SYSTEM; PHILIPS ST8OI STRESS TEST SYSTEM Back to Search Results
Model Number 860343
Device Problem Failure to Auto Stop (2938)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
A follow-up report will be submitted once the investigation is complete.
 
Event Description
The customer reported being unable to stop the treadmill, indicating neither the emergency stop button(esb) nor the lanyard stopped the treadmill.Patient involvement is unknown.
 
Manufacturer Narrative
Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
 
Event Description
The customer reported being unable to stop the treadmill, indicating neither the emergency stop button(esb) nor the lanyard stopped the treadmill.The device was not in use on a patient.There was no reported patient or user harm.
 
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Brand Name
ST8OI STRESS TEST SYSTEM
Type of Device
PHILIPS ST8OI STRESS TEST SYSTEM
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
MDR Report Key10408059
MDR Text Key203636768
Report Number1218950-2020-04735
Device Sequence Number1
Product Code DQK
UDI-Device Identifier00884838030299
UDI-Public(01)00884838030299
Combination Product (y/n)N
PMA/PMN Number
K121638
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 07/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number860343
Device Catalogue Number860343
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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