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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PAGEWRITER TC30 CARDIOGRAPH
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PHILIPS MEDICAL SYSTEMS PAGEWRITER TC30 CARDIOGRAPH Back to Search Results
Model Number 860306
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
A follow-up report will be submitted once the investigation is complete.
 
Event Description
Customer reported that a patient received unnecessary emergency care based upon a false reading received from the tc30.The device was in use monitoring a patient.Currently unknown if harm was caused by the unnecessary care.
 
Event Description
Customer reported that a patient received unnecessary emergency care based upon a false reading received from the tc30.The device was in use monitoring a patient.The customer confirmed there was no patient harm.
 
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Brand Name
PAGEWRITER TC30 CARDIOGRAPH
Type of Device
PAGEWRITER TC30 CARDIOGRAPH
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
robert corning
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key8862127
MDR Text Key153406501
Report Number1218950-2019-05782
Device Sequence Number1
Product Code DPS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113144
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/10/2019
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 Number860306
Device Catalogue Number860306
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/10/2019
Initial Date FDA Received08/05/2019
Supplement Dates Manufacturer Received07/10/2019
Supplement Dates FDA Received08/19/2019
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
Patient Sequence Number1
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