MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PATIENT INFORMATION CENTER IX

Model Number 866389

Device Problem Alarm Not Visible (1022)

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

Event Date 01/10/2024

Event Type  malfunction  

Event Description

The customer reported that the device presented that the battery alarm on cardio telemetry missing.It is unknown if the device was in use at time of event, there was no adverse event reported.

Manufacturer Narrative

Philips is in the process of obtaining additional information regarding the reported event and the investigation is ongoing.A follow-up report will be submitted upon completion of the investigation.(b)(6).

Manufacturer Narrative

The remote service engineer (rse) reviewed the log files provided by the customer, but the log files received did not contain the time in question.The rse contacted the customer again to request the audit log files that contained the time in question.The client stated that they did not wish to investigate further and did not provide the logs.Philips cannot rule out a malfunction of the device, as provided log files from the customer did not contain for the reported time of event, which was needed to perform a full investigation, was not provided by the customer and the exact cause for the reported issue remains unknown.

Event Description

The device was in use at time of event, there was no adverse event reported.

• Brand Name: PATIENT INFORMATION CENTER IX
• Type of Device: PATIENT INFORMATION CENTER IX
• 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 ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 18606797
• MDR Text Key: 334100789
• Report Number: 1218950-2024-00057
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838104594
• UDI-Public: 884838104594
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K211900
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 866389
• Device Catalogue Number: 866389
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2024
• Initial Date FDA Received: 01/30/2024
• Supplement Dates Manufacturer Received: 01/29/2024
• Supplement Dates FDA Received: 02/12/2024
• 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