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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 Fire (1245)
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 the battery an cardiograph caught on fire.There was no patient harm or injury reported.
 
Manufacturer Narrative
The investigation determined that use of a battery outside of its specifications was the cause.For customer satisfaction purposes, a new tc30 cardiograph was shipped to the customer and all batteries onsite were checked for cycle count.2 additional batteries were removed for having a high cycle count; however, no issues were reported with either battery.Investigation concludes the product was used beyond it's expected useful life.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
Customer reported the battery an cardiograph caught on fire.The device was not in use on a patient.
 
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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
MDR Report Key10149995
MDR Text Key195364864
Report Number1218950-2020-03426
Device Sequence Number1
Product Code DPS
Combination Product (y/n)N
PMA/PMN Number
K113144
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 06/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2020
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? Device Returned to Manufacturer
Date Returned to Manufacturer08/27/2020
Was the Report Sent to FDA? No
Date Manufacturer Received06/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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