MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PIC IX HARDWARE

Model Number 866424

Device Problem No Audible Alarm (1019)

Patient Problems Hypoxia (1918); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/29/2022

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

The customer reported that there was no alarm generated by the patient information center pic ix when the patient's spo2 vitals in room 31t dropped below the desaturation alarm limit.The device was in use monitoring a patient at the time of the reported event.Staff intervention had to be performed to assist the patient.

Manufacturer Narrative

It was verified the spo2 data was being displayed at the surveillance at the time alleged, logs files were captured that showed this.Customer was able to provide pictures and wave strips, log files, archive and clinical audit and device statuses from the surveillance.The fse deteremined there was no product malfunction as the device worked as intended on the piic.The initial no alarm was determined via logs to be a configuration issue at the mp5sc where the customer had the default volume to off instead of on.Clinical specialist remedied this situation.The device was confirmed to be operating per specifications and no failure was identified.The device remains at customer site.

Event Description

The customer reported that there was no alarm generated by the patient information center pic ix when the patient's spo2 vitals in room 31t dropped below the desaturation alarm limit.The customer confirmed there was no patient harm reported.

• 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: 16245332
• MDR Text Key: 308144048
• Report Number: 1218950-2023-00051
• 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?: 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?: Yes
• Initial Date Manufacturer Received: 12/29/2022
• Initial Date FDA Received: 01/26/2023
• Supplement Dates Manufacturer Received: 04/21/2023
• Supplement Dates FDA Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2017
• 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): Required Intervention