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

Model Number 866389

Device Problem Defective Alarm (1014)

Patient Problem Unspecified Heart Problem (4454)

Event Date 07/28/2023

Event Type  Death  

Manufacturer Narrative

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

Event Description

The customer claims a failure to alarm, and missing alarm logs.The customer reported that patient passed away.

Manufacturer Narrative

This supplemental report is being submitted with reference to manufacturer's report 1218950-2023-00599.The customer biomedical engineer has stated that there was no device malfunction.Philips is in process of obtaining additional information.A final report will be submitted upon completion of the investigation.

Manufacturer Narrative

A philips remote service engineer (rse) spoke with the customer and confirmed that "on (b)(6) 2023 a patient passed and the staff are stating it did not alarm." the biomed requested audit logs of 12 hr period between 10am - 10pm.There was no information on what alarms failed.The rse answered biomed questions regarding clinical audit, and alarm behaviors (audio play and stop sounds) explaining that this is a central station characteristic (pic wide).Every time the speaker plays it is logged regardless of sorting by bed label.The sector cleared is done by pic and is not sorted on bed label search.A philips remote application specialist (ras) also assisted the biomed reviewing alarms and inops (technical alarms) table, alarm latching behavior, philips star arrhythmia monitoring application, (pic ix) clinical audit information.The biomed was emailed all documentation reviewed.Pimr-product incident malfunction report intake notes that device actions taken= biomed does show the pic alarmed.An onsite service was requested for a philips field service engineer (fse) official clinical audit review.The fse explained the process for onsite report audit review, and the biomed informed that he had all clinical audit logs and no action was needed from philips.The fse stated "we explained to the customer that there is a specific procedure for this kind of requests, they declined onsite service, and i closed the work order without being onsite.We didn¿t have any investigation for this case, biomed was able to pull clinical audit log from the system and asked to close the case." on (b)(6) 2023, the customer biomed stated , "i want to clarify that there was no equipment malfunction during the patient incident." and the director, risk management (b)(6) hospital stated, "we are not aware of any monitor issue or failure.We have no information related to the incident below.There were no monitor issues related to that incident." further requests to confirm if the device alarmed and worked as intended were not answered.Based on the information available there was no allegation of product malfunction, only a request for customer assistance.There was not a reported device problem.The engineers provided their analysis findings however we are unable to confirm the final disposition of the device because the customer did not respond to requests for additional information.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• 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: 17615177
• MDR Text Key: 321871511
• Report Number: 1218950-2023-00599
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153702
• 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

• Is this an Adverse Event Report?: Yes
• 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: 07/31/2023
• Initial Date FDA Received: 08/24/2023
• Supplement Dates Manufacturer Received: 07/31/2023; 07/31/2023
• Supplement Dates FDA Received: 09/18/2023; 10/24/2023
• 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
• Patient Outcome(s): Death