MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PIIC CLASSIC UPGRADE

Model Number 866117

Device Problem No Audible Alarm (1019)

Patient Problems Unspecified Respiratory Problem (4464); Insufficient Information (4580)

Event Date 01/31/2023

Event Type  Injury  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

The customer reported the system did not alarm and due to this issue, the patient condition is critical.

Manufacturer Narrative

Section b event date was corrected from 02/01/2023 to 01/31/2023.The field service engineer (fse) went to the customer's site and was unable to reproduce the customer's issue.No other problems were detected during testing, the device was fully functional.The fse pulled logs and clinical audit data.The product support engineer (pse) analyzed the logs.The bedside ivpm bedside xmon14 alarm review photos provided prove that there were alerts, including red alerts at 10:18 am, 10:22 am, and 10:24 am, for the bed during the timeframe of 10:12 am to 10:29 am.For the nibp measurement, there could not be an alert for the time of approximately 10:20 am since the last nibp measurement was done at 09:28 am.The nibp measurement was likely set to manual by user, instead of automatic (default).For the spo2 measurement, the spo2 sensor was detached at 10:17 am from the finger.This was a technical inop announced as a cyan alarm, but as there were other higher alarms raised (red ecg vent fib/tachy), only the red alarms were announced.Since the spo2 sensor was detached, there could not be any other alarms afterwards for spo2.There were several ecg red alerts for the timeframe alleged.The monitor seems to have been disconnected from the central for approximately 35 seconds, which means for that for the alleged timeframe, no alerts of bedside ivpm xmon14 were given at the picix.Nevertheless, the ivpm bedside xmon14 alerted this condition to the user by an inop ¿no central¿, and this alert was silenced at the ivpm bedside xmon14 by the user according to the picix audit log.Which leads to the conclusion that a clinical user was operating the ivpm bedside xmon14.The pic ix log confirmed the conditions seen at ivpm bedside xmon14 alarm review including the disconnect situation.It cannot be determined why the ivpm bedside xmon14 got disconnected.Nevertheless, the ivpm bedside xmon14 alerted during that timeframe independently, which seem to be noticed by the user.

Event Description

Additional information was received that on (b)(6) 2023, at 12:05 pm the system did not alarm for non-invasive blood pressure (nbp) and oxygen saturation (spo2) red alarms.The result was the patient developed acute pulmonary decompensation which required resuscitation.

• Brand Name: PIIC CLASSIC UPGRADE
• Type of Device: PIIC CLASSIC UPGRADE
• 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: 16459150
• MDR Text Key: 310413624
• Report Number: 1218950-2023-00106
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K081983
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/28/2023

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: 866117
• Device Catalogue Number: 866117
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2023
• Initial Date FDA Received: 03/01/2023
• Supplement Dates Manufacturer Received: 03/21/2023
• Supplement Dates FDA Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/08/2014
• 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; Life Threatening; Other
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 100 KG