MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PAGEWRITER TOUCH CARDIOGRAPH; PAGEWRITER TC70 CARDIOGRAPH

Model Number 860315

Device Problems Fire (1245); Noise, Audible (3273)

Patient Problem Electric Shock (2554)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported the monitors shut down and there was a loud noise and a flame coming from the power cord when attaching the ekg-device to the wall.The user was holding the handle of the device and got an electric shock to the left hand.

Manufacturer Narrative

The user was holding the plug in the wall socket and received a tingling in the fingers, wrist and arm and a slight headache.There was no treatment needed.The injury is not considered serious as no medical intervention was required and there was no permanent impairment.The customer contacted the customer care solution center (ccsc) for trouble shooting.A field service engineer (fse) confirmed that the problem was caused by the wall socket, and is not considered a product malfunction.The fse recommended that the customer replace the network cable, pin module cable and power cord.

• Brand Name: PAGEWRITER TOUCH CARDIOGRAPH
• Type of Device: PAGEWRITER TC70 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: 8404112
• MDR Text Key: 138248770
• Report Number: 1218950-2019-01881
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K020708
• 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: 03/05/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 860315
• Device Catalogue Number: 860315
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/20/2012
• 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