MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PAGEWRITER TC20 CARDIOGRAPH

Model Number 860332

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted once the investigation is complete.

Event Description

Customer reported device got unexpectedly burnt.There was no patient injury/harm in association with this event.

Event Description

Customer reported device got unexpectedly burnt.The customer confirmed that the device was not connected to a patient when this event happened.There was no patient injury/harm in association with this event.

• Brand Name: PAGEWRITER TC20 CARDIOGRAPH
• Type of Device: PAGEWRITER TC20 CARDIOGRAPH
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS HEALTHCARE - ANDOVER; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: rana ata ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 8043562
• MDR Text Key: 126397283
• Report Number: 1218950-2018-08644
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/29/2018

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 Number: 860332
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/29/2018
• Initial Date FDA Received: 11/06/2018
• Supplement Dates Manufacturer Received: 10/29/2018
• Supplement Dates FDA Received: 03/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2015
• 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