MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PIC IX HARDWARE

Model Number 866424

Device Problems Device Alarm System (1012); Human-Device Interface Problem (2949)

Patient Problem Arrhythmia (1721)

Event Date 06/05/2023

Event Type  Death  

Event Description

The customer reported that the clinical staff claimed that the picix central station did not alarm when a patient had arrhythmia and the patient passed away.

Manufacturer Narrative

Philips is in process of obtaining additional information.A final report will be submitted upon completion of the investigation.

Manufacturer Narrative

The complaint was escalated for technical investigation including log file review, and the data for the timeframe associated with the patient and devices involved indicate that certain alarms and measurements were turned off by the user prior to the patient arrythmia.Based on the information available from the logs and data, the cause of the reported problem was deactivation of ecg/arrythmia alarms and respiration measurements as well as extended periods of ecg leads off, which led to delayed recognition of the patient condition.Based on the information available from the logs and data, the cause of the reported problem was alarms and measurements being turned off or silenced, leading to the delay in recognition of the patient condition.The device was determined to have functioned as per specification and regulatory reports for (b)(4) will be sent to address the details of the technical investigation including log file review.The device is operational.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, ( pic ix ) indicating that the central station did not alarm when patient had arrhythmia.The patient admitted onto central ecg/arrhythmia alarms turned off at 17.56.Patient went into arrythmia at 5.26 next dayon (b)(6) 2023 resulting in death.

• 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 ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 17224141
• MDR Text Key: 318076198
• Report Number: 1218950-2023-00446
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K102495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• 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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/29/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2016
• 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