MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PIC IX HARDWARE

Model Number 866424

Device Problem Wireless Communication Problem (3283)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/08/2022

Event Type  malfunction  

Event Description

It was reported that the customer had lost central monitoring for 13 hours and 38 minutes.The device was in use during the event but no harm was reported.

Manufacturer Narrative

A follow-up report will be submitted when additional information is received or upon completion of the investigation.Reporting institution phone # (b)(6).

Event Description

Problem statement: it was reported that the central station had connectivity issue.As the event was reportable to a regulatory authority and indicated a possible failure of a device, labeling, or packaging to meet any of its specifications, an investigation was required.Patient/user involvement: was the device being used on a patient at the time of the event, including for the purposes of diagnosis? yes, the device was in use on a patient at the time of the reported issue.Was there any adverse event to the patient or user? no.Complaint evaluation: analysis of logs sent to the client on 08/11/2022.Restart due to a loss of connection between the enterprise link durran and the primary melekeok server.Conclusion: per sap work order number (b)(4), the device was remotely diagnosed and recommended the reboot to connect all three devices.No further investigation or action is warranted.

• Brand Name: PIC IX HARDWARE
• Type of Device: PIC IX HARDWARE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15815534
• MDR Text Key: 307081905
• Report Number: 1218950-2022-00995
• 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

• Date FDA Received: 11/17/2022
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2019
• 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