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

Model Number 866389

Device Problems Device Alarm System (1012); False Alarm (1013)

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

Event Date 01/05/2024

Event Type  malfunction  

Event Description

The customer reported that the red alarms are going off from the device.It is unknown if the device was in use at time of event, there was no adverse event reported.

Manufacturer Narrative

Philips is in the process of obtaining additional information regarding the reported event and the investigation is ongoing.A follow-up report will be submitted upon completion of the investigation.

Event Description

The customer reported that the red alarms are going off / false alarms from the patient information center ix.The device was in use at time of event, there was no adverse event reported.

Manufacturer Narrative

After further investigation this was deemed not a reportable event with philips.The customer reported that the red alarms are going off / false alarms from the patient information center ix.The philips field service engineer (fse) went for onsite service and tested the devices and confirmed that the patient information center ix alarmed as expected during the visit onsite.The fse escalated the case to the national support specialist (nss) for further investigation.During the on-site visit by the nss, several observations were made that could have been the cause of the false alarm.Third-party mx40 lead sets are being used on the customer's mx40s - they are not validated by philips; clinical staff is not performing skin prep before the application of ecg electrodes; multiple patients have excess ecg electrodes attached to their skin; staff will need to understand the importance of ecg lead placement.Based on the information provided in the case, the alarms functioned as expected.The customer was provided with the site visit report by the clinical nss (national support specialist) that contains recommendations along with philips-branded documentation on how to prevent and troubleshoot the ecg issues that can result in false asystole alarms on the pic ix.

• 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: 18604651
• MDR Text Key: 334027619
• Report Number: 1218950-2024-00056
• 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: K143057
• 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?: 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2024
• Initial Date FDA Received: 01/30/2024
• Supplement Dates Manufacturer Received: 03/22/2024
• Supplement Dates FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2017
• 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