MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PAGEWRITER TC50 CARDIOGRAPH

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

The customer reported that during a timed ecg sequence, which was being used for an ajmaline study, the ecg machine froze.The machine stopped printing ecg and would not respond to interaction.There was no report of a death or serious injury in association with this event.

Event Description

The customer reported that during a timed ecg sequence, which was being used for an ajmaline study, the ecg machine froze.The machine stopped printing ecg and would not respond to interaction.The device was in use on a patient and there was no adverse event.

• Brand Name: PAGEWRITER TC50 CARDIOGRAPH
• Type of Device: PAGEWRITER TC50 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 Key: 6961640
• MDR Text Key: 89989688
• Report Number: 1218950-2017-07275
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K080999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2017

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/05/2017
• Initial Date FDA Received: 10/19/2017
• Supplement Dates Manufacturer Received: 10/05/2017; 10/05/2017
• Supplement Dates FDA Received: 02/20/2018; 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2017
• 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