MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PIC IX HARDWARE

Model Number 866424

Device Problem Wireless Communication Problem (3283)

Patient Problem Insufficient Information (4580)

Event Date 10/06/2022

Event Type  Injury  

Event Description

The customer reported that all centralized monitoring within their facility was down for 12 minutes.During the down time an unspecified patient incident occurred.

Manufacturer Narrative

A follow-up report will be submitted when additional information is received or upon completion of the investigation.

Manufacturer Narrative

This follow up was created in error.The previous follow up report was completed.

Event Description

Statement of the reported problem: this report is based on information provided by philips field service engineer personnel and has been investigated by the philips complaint handling team.Philips received a complaint on the pic ix indicating that the central stations at the facility went down on (b)(6) 2022 at 1300 to 13:12.For a period of 12 minutes and came back by themselves.The biomed stated that the patient vitals were not able to be viewed at the nurse station, only at the bedside.It was reported that during the downtime there was a possible patient injury.The biomed requested a philips field service engineer come onsite o pull the audit logs and gather other information about the patient event.Functional testing/service repair/technical investigation: the following functional tests were performed: a philips field service engineer went onsite and confirmed the event occurred on (b)(6) 2022 at 1300 to 13:12.The fse obtained the device logs and confirmed that -found nt4-access-115 and ww-254-dista-55 both went down at 13:06 on (b)(6) 2022.Both switches came back on at 13:09.Transceivers were inserted into both switches at 08:27 and 8:39.Found multiple fiber terminations unplugged from both switches.Pulled pablo scan and solarwinds to verify network connections.It was recommended to follow up and check pablo and solarwinds and make changes if needed.An additional work order was created, (b)(4) to have the philips fse to go back onsite to check the customer network.Confirmation: a good faith effort was made to obtain additional information about the issue, devices involved and the report of a possible patient injury.The customer would not provide any additional information.All questions were answered with asked but unknown.There were no logs available from the pic ix as the device was not connected to the system when the switches went down.Further action decision: based on the information available and results of additional analysis, no further action is necessary at this time.Risk analysis: a review of the risk management file was performed and while philips devices provide mitigations related to the loss of centralized wireless monitoring (ie ¿no central mon¿ inop, visual and audible tones, local monitoring for mx40), a malfunction that leads to the loss of monitoring for numerous patients using mixed wireless devices may result in a delayed response to an individual patient requiring emergent care.Clinical harm review an assessment was performed based on the information currently available.Upon review of the information, there was no injury or death noted within the complaint record.A 'patient incident' was reported but there is no information if this was an injury or death.I the customer would not confirm the patient incident.Trending statement: the data entered in this complaint record will be utilized for product quality and safety improvements per the post market surveillance and risk management processes.Closure & product disposition: the engineer provided their analysis findings however we are unable to confirm the final disposition of the device because the customer did not want to provide any additional information.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.Was the device being used on a patient at the time of the event, including for the purposes of diagnosis? yes the device was in clinical use at the time.Was there any adverse event to the patient or user? if yes, describe? yes customer reported a possible adverse event.There was a report of a possible patient injury if there was an adverse event, did the device cause or contribute to the adverse event, and how? the possible event and the device involvement could not be confirmed.

• 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 ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15714027
• MDR Text Key: 302836684
• Report Number: 1218950-2022-00957
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Date Manufacturer Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2019
• 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