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

Model Number 866424

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure of Implant (1924)

Event Date 01/27/2022

Event Type  Injury  

Manufacturer Narrative

A philips remote service engineer (rse) spoke with the customer.The customer biomed wanted to know if it is possible to store patient data digitally instead of printing it out on paper.There was not an incident or complaint towards philips products.The rse informed the biomed that it is possible to stored patient data digitally.The biomed wanted to check with staff before moving forward.Upon follow-up, the rse learned that the biomed had not yet spoken with the ward manager and the decision was made to close the case.There was no product malfunction.There was no incident or complaint against a philips product.The rse provided information to the customer to address the question.

Event Description

Biomedical engineer reported that the customer wanted to know if they could save a digital image of an electrocardiogram (ecg) and an arterial blood pressure (abp) curve from an incident where a pacemaker went wrong.

• Brand Name: PIC IX HARDWARE
• Type of Device: PIC IX HARDWARE
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: derek sammarco ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 13506963
• MDR Text Key: 285410978
• Report Number: 1218950-2022-00117
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K102495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 866424
• Device Catalogue Number: 866424
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2022
• Initial Date FDA Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/11/2019
• 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
• Patient Outcome(s): Hospitalization