MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC PIC IX HARDWARE

Model Number 866424

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/24/2021

Event Type  malfunction  

Event Description

The customer reported there was a discrepancy between trace carried out with philips monitoring 12-lead ecg and the electrocardiograph.The device was reported to be in use on a patient, but no adverse event to patient or user was reported.

Manufacturer Narrative

The product and registration number changed.Please refer to 9610816-2021-10185 for complete report.

• Brand Name: PIC IX HARDWARE
• Type of Device: PIC IX HARDWARE
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• MDR Report Key: 11423418
• MDR Text Key: 235031256
• Report Number: 1218950-2021-10082
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K102495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup

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: 866424
• Device Catalogue Number: 866424
• Distributor Facility Aware Date: 02/24/2021
• Initial Date Manufacturer Received: 02/24/2021
• Initial Date FDA Received: 03/05/2021
• Supplement Dates Manufacturer Received: 02/24/2021
• Supplement Dates FDA Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1