MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC PATIENT INFORMATION CENTER IX

Model Number 866389

Device Problems No Audible Alarm (1019); Insufficient Information (3190)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2022

Event Type  Death  

Manufacturer Narrative

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

Event Description

The customer reported a patient death but unsure if it was related to the monitor or the staff not responding to alarms.The fse reviewed with the customer on how inop alarms occur for ecg leads off and ecg leads unplugged.The customer also checked the configuration on the picix and found ecg leads off set to yellow inop severity and ecg leads unplugged = ecg leads off set to off.

Event Description

Philips received a complaint on the mx40 and the patient information center ix indicating issues regarding inoperative (inop) alarms.The patient has deceased in this event.The focus on this record investigation will be on the patient information center ix.The mx40 is linked to (b)(4) (mfr report number 1218950-2022-01034).After reviewing the logs, the product support engineer (pse) confirmed on bed u631a on the date of the event (10/19/2022), it was seen that pic ix 6west-ix had many alarms and interactions from the clinician.Based on the information available and the testing conducted, the cause of the reported problem was the staff silencing the alarms.The reported problem was not confirmed.Based on the information available and results of additional analysis, no further action is necessary at this time.A review of the risk management file and risk analysis was performed and there has been no clarification by the customer on any allegation of deficiency which may have caused or contributed to the death; however, per the review of the logs by the product support engineer, it was indicated alarms were displayed and silenced by the user multiple times.According to this information, it does not appear as if there is enough information to indicate the device caused or contributed to the death.Furthermore, clinical assessment states the customer was requesting assistance to understand the leads off alarm behavior, which was provided.There is no indication the device caused or contributed to the patient death at this time.In addition, log file review indicated alarms were displayed and users were silencing them.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 NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15820485
• MDR Text Key: 303888169
• Report Number: 1218950-2022-01008
• 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: K153702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• 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?: No
• Device Operator: Health Professional
• Device Model Number: 866389
• Device Catalogue Number: 866389
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2022
• Initial Date FDA Received: 11/17/2022
• Supplement Dates Manufacturer Received: 12/21/2022
• Supplement Dates FDA Received: 01/13/2023
• Date Device Manufactured: 11/24/2015
• 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): Death