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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Type  Malfunction  
Manufacturer Narrative

The customer stated that after a patient expired, they were attached to a cardiograph to document that the patient died and have documentation in the patient file. The customer confirmed the patient had expired prior to being attached to the cardiograph and that the device in no way contributed to the patient death. The customer submitted a feedback stating they expected a different interpretation that what was given. There is no information that supports that this failure could potentially cause misdiagnosis or injury to the patient or users. There is no known safety risk. The customer confirmed the device is working as intended but expected a different interpretation. The customer stated that per hospital protocol, after a patient dies, they attach a cardiograph to document/confirm the death. They expected a different interpretation than what was provided [¿not enough leads could be measured: missing leads: ii, iii, avl, avf, v1, v3, v5, v6. ¿]. The customer expected a more clinical diagnosis than just no leads could be measured. Information was provided to the customer from product support and advanced algorithm team lead which stated that the device is not able to make an interpretation of asystole on a patient with no electrical pulses. The device could not find any electrical pulses and stated that no leads could be measured. This is not a malfunction of the device and the device did not contribute to the death of the patient. The device remains at the customer site and in use. There have been no additional calls from the customer to report the same failure.

 
Event Description

The customer stated that after a patient expired, they were attached to a cardiograph to document that the patient died and have documentation in the patient file. The customer submitted a feedback stating they expected a different interpretation that what was given. The customer confirmed the patient had expired prior to being attached to the cardiograph and that the device in no way contributed to the patient death.

 
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Brand NamePAGEWRITER TC30 CARDIOGRAPH
Type of DevicePAGEWRITER TC30 CARDIOGRAPH
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
wendy chadbourne
3000 minuteman road
andover, MA 01810
MDR Report Key5322259
MDR Text Key34771839
Report Number1218950-2015-06985
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)N
Reporter Country CodeTU
PMA/PMN NumberK113144
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation
Type of Report Initial
Report Date 12/10/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/23/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL Number860306
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/15/2015
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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