MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PIC IX HARDWARE

Model Number 866424

Device Problems No Audible Alarm (1019); Insufficient Information (3190)

Patient Problems Arrhythmia (1721); Insufficient Information (4580)

Event Date 12/02/2022

Event Type  Injury  

Event Description

The customer reported that a patient was found pulseless and they wanted to confirm that the philips equipment operated correctly.

Manufacturer Narrative

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.

Event Description

This report is based on information provided by a philips remote service engineer (rse) personnel and has been investigated by the philips complaint handling team.Philips received a complaint on the patient information center ix (pic ix) indicating that the device did not alarm during the time in question.Results of functional testing indicated that per the audit logs, the pic ix system did alarm and functioned as expected.Based on the information available and the testing conducted we were unable to replicate the reported problem.The reported problem was not confirmed.Based on the information available and results of additional analysis, no further action is necessary at this time.The clinical assessment states the audit trail indicated the device alarmed as expected; therefore, a failure to alarm did not occur and the device did not cause or contribute to the patient injury.The device was confirmed to be operating per specifications and no failure was identified.The investigation concludes that no further action is required at this time.

• 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: 16036356
• MDR Text Key: 306019787
• Report Number: 1218950-2022-01069
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102495
• 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

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?: No
• 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: 12/02/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 01/09/2023
• Supplement Dates FDA Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2022
• 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): Life Threatening
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 97 KG