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

Model Number 866424

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 10/15/2021

Event Type  Death  

Manufacturer Narrative

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

Event Description

The customer reported that an undesirable event occurred and that they needed assistance pulling the audit log data from one specific patient.The details of the adverse event are unknown.

Manufacturer Narrative

A philips remote service engineer (rse) talked to the customer to resolve the customers request.The rse assisted the customer by pulling the patient's data.Additional information regarding the event was requested but was not received after multiple attempts.If additional information is received this case shall be reopened.Their is insufficient information to conclude whether there was any malfunction or not.The rse was able to provide the customer with the audit logs that were requested.

Event Description

The customer reported that an undesirable event occurred and that they needed assistance pulling the audit log data from one specific patient.

• 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: 12680042
• MDR Text Key: 277846216
• Report Number: 1218950-2021-11047
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup

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?: Yes
• 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: 10/15/2021
• Initial Date FDA Received: 10/22/2021
• Supplement Dates Manufacturer Received: 10/15/2021
• Supplement Dates FDA Received: 12/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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): Death