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

Model Number 866389

Device Problems Device Alarm System (1012); Defective Alarm (1014)

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

Event Date 03/04/2024

Event Type  malfunction  

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

Patient disconnected their arterial line and central did not alarm.The device was in use on a patient.There was no patient harm.Staff were able to place a new arterial line and the patient was stable.

Event Description

The customer reported that a patient disconnected their arterial line and the central station did not alarm.The device was in use on a patient.There was no patient harm.Staff were able to place a new arterial line and the patient was stable.

Manufacturer Narrative

It was indicated via good faith effort (gfe) that the staff did not witness the arterial line being disconnected and there was a delay in intervention; however, at this time, the information available also indicates no actual patient harm occurred, a new arterial line was placed, and the patient was stable.The following functional tests were performed: a remote service engineer (rse) pulled the audit logs and strips for review.A clinical product specialist reviewed the clinical audit log and data provided.The clinical audit log does not indicate an arterial line disconnect red alarm was announced.However, we cannot confirm an inop was not present for the arterial line due to pic ix b.02.17 release does not log every single inop.The clinical audit log shows an ¿ecg leads off¿ inop generated at 04:03:50.This alarm was silenced by the user at the pic ix at 4:08:01.The ¿ecg leads off¿ inop ended at 04:14:56.Based on the information available, we confirm that the monitor did not generate an ¿***abp disconnect¿ alarm.The rhythm strip indicated that an abp inop/technical alarm was active which interrupted the alarm generation of the disconnect alarm which may have resulted from a broken transducer.Attempts to obtain and to evaluate the transducer in question failed, as the consumable part has been disposed of after usage.The audit log shows other alarms were announced including the ecg leads off inop at 04:03:50.Based on the information available and results of additional analysis, no further action is necessary at this time.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.If additional information is received the complaint file will be reopened.H3 other text : see h10.

• 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: deborah currlin ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 18995808
• MDR Text Key: 338835882
• Report Number: 1218950-2024-00226
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838048645
• UDI-Public: 00884838048645
• 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

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: 04/16/2024
• Supplement Dates FDA Received: 05/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/14/2015
• 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 Age: 60 YR
• Patient Sex: Male