MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PAGEWRITER TC30 CARDIOGRAPH

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.

• 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: wendy chadbourne ; 3000 minuteman road; andover, MA 01810
• MDR Report Key: 5322259
• MDR Text Key: 34771839
• Report Number: 1218950-2015-06985
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K113144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 860306
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2015
• 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
• Patient Sequence Number: 1