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

Model Number 866389

Device Problems No Audible Alarm (1019); Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 09/01/2023

Event Type  malfunction  

Event Description

The customer reported that there was a delay in treatment on (b)(6) 2023 at approx.0300 hrs, rm #3119/3 south.Spo2 alarms were allegedly turned off by clinical staff on mp70 ivpm.The customer is requesting onsite support for philips to investigate the incident by pulling logs from ivpm/picix and evaluated by q/r.

Manufacturer Narrative

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

Manufacturer Narrative

The following functional tests were performed: spo2 alarm was not going off for patient and patient went into low oxygen alarm and no alarm sound from the monitor was heard.The field service engineer (fse) later found that the customer was turning off spo2 alarms on certain monitors.Fse retrained the customer on devise use.Delay in treatment was reported but no patient info was known or made available 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.

• 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: 17819380
• MDR Text Key: 324286172
• Report Number: 1218950-2023-00693
• 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
• 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?: 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: 09/01/2023
• Initial Date FDA Received: 09/26/2023
• Supplement Dates Manufacturer Received: 09/01/2023
• Supplement Dates FDA Received: 10/20/2023
• 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): Other