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

Model Number 866389

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

Patient Problem Insufficient Information (4580)

Event Date 12/05/2023

Event Type  Injury  

Event Description

Customer requested assistance pulling patient logs on a discharged patient.There was an unspecified patient incident.The device was in use.There was an unspecified patient injury reported.

Manufacturer Narrative

A philips technical consultant went to the customer¿s site and provided the logs to the customer.Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

Manufacturer Narrative

Type of reportable event was corrected from product problem to serious injury.

Manufacturer Narrative

Biomed requested the philips field service engineer(fse) retrieve the clinical audit logs for review.The fse retrieved the logs and provided them to the customer.A good faith effort(gfe) was completed to obtain further details but customer stated they did not have any other details.The reported problem was not confirmed.The risk management review of safety risk assessment(sra) indicated that there was no alleged malfunction of the device, and there was nothing to believe the product caused or contributed to any patient harm.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

Event Description

Philips received a complaint on the patient information center ix indicating that "need to pull patient logs on discharged patient to identify incident information." the device was in clinical use.There was an unspecified patient harm 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: 18355071
• MDR Text Key: 330877100
• Report Number: 1218950-2023-00951
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211900
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 866389
• Device Catalogue Number: 866389
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Other