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

Model Number PATIENT INFORMATION CENTER IX

Device Problems Communication or Transmission Problem (2896); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 09/19/2022

Event Type  Death  

Manufacturer Narrative

Concomitant products included as part of this report include: pr-2503097, catalog item name tele assy sync unit, catalog item identifier 453564025901, serial number (b)(4).Pr-2503315, catalog item name tele assy sync unit, catalog item identifier 453564025901, serial number (b)(4).Pr-2503338, catalog item name tele mx40, 2.4 ghz, ecg &sp02, exchange, catalog item identifier 453564262551, serial number (b)(4).A follow-up report will be submitted upon completion of the investigation and cross reference to include mfg report number for pr 2503338.

Event Description

Fault situation of the its telemetry system.In the event of a failure, the vital signs of telemetry monitored (mx40) patients were not displayed in the philips patient information center ix (pic ix) central monitoring system and their alarms were not transferred to the pic ix central monitoring system.The failure caused a disturbance in the ward, as a result of which one patient died.The fault was found on (b)(6) 2022 at 8:30 by nurses.Patients were connected to mx40 devices and it was moved to monitoring mode.Patient monitoring was continued even though the connection to the pic ix center was lost.The patient's weak condition was noted on (b)(6) 2022 at 17:45, when the nurses had visited the patient.The telemetry device was found to have turned off because it had run out of batteries (not able to generate alarms).Attempts had been made to resuscitate the patient, but it was unsuccessful.The patient was dead at 18:05.

Event Description

Fault situation of the its telemetry system.In the event of a failure, the vital signs of telemetry monitored (mx40) patients were not displayed in the philips patient information center ix (pic ix) central monitoring system and their alarms were not transferred to the pic ix central monitoring system.The failure caused a disturbance in the ward, as a result of which one patient died.The fault was found on (b)(6) 2022 at 8:30 by nurses.Patients were connected to mx40 devices and it was moved to monitoring mode.Patient monitoring was continued even though the connection to the pic ix center was lost.The patient's weak condition was noted on (b)(6) 2022 at 17:45, when the nurses had visited the patient.The telemetry device was found to have turned off because it had run out of batteries (not able to generate alarms).Attempts had been made to resuscitate the patient, but it was unsuccessful.The patient was dead at 18:05.A philips service operations manager (som) contacted the customer biomedical engineer (biomed).Per the som, it was not known exactly whether the mx40 device had alerted about the battery running out.If it did the end users had not heard or noticed it.The pic ixs its telemetry system had been in failure mode (system down) about 12 hours before the event.At that time, the mx40 devices operated in the monitoring mode (standalone), i.E.Mx40 were not connected to pic ix central monitoring.The mx40 battery end log data was not available because the its system was down, thus the log data was not updated to the pic ix system.Running out of the mx40 battery is the likely reason that the device had turned off, because the mx40 device had returned to normal operation as soon as its battery was replaced.The som indicated that the root cause for the its system down turned out to be a network hardware failure; the trunk fiber cable between the data switches failed.The fault was fixed by the hospital's biomed/ict staff the next day.The device remains at the customer site.No further investigation or action is warranted at this time.Cross reference mfg report number 1218950-2022-00923.

Event Description

Fault situation of the its telemetry system.In the event of a failure, the vital signs of telemetry monitored (mx40) patients were not displayed in the philips patient information center ix (pic ix) central monitoring system and their alarms were not transferred to the pic ix central monitoring system.The failure caused a disturbance in the ward, as a result of which one patient died.The fault was found on (b)(6) 2022 at 8:30 by nurses.Patients were connected to mx40 devices and it was moved to monitoring mode.Patient monitoring was continued even though the connection to the pic ix center was lost.The patient's weak condition was noted on (b)(6) 2022 at 17:45, when the nurses had visited the patient.The telemetry device was found to have turned off because it had run out of batteries (not able to generate alarms).Attempts had been made to resuscitate the patient, but it was unsuccessful.The patient was dead at 18:05.A philips service operations manager (som) contacted the customer biomedical engineer (biomed).Per the som, it was not known exactly whether the mx40 device had alerted about the battery running out.If it did the end users had not heard or noticed it.The pic ixs its telemetry system had been in failure mode (system down) about 12 hours before the event.At that time, the mx40 devices operated in the monitoring mode (standalone), i.E.Mx40 were not connected to pic ix central monitoring.The mx40 battery end log data was not available because the its system was down, thus the log data was not updated to the pic ix system.Running out of the mx40 battery is the likely reason that the device had turned off, because the mx40 device had returned to normal operation as soon as its battery was replaced.The som indicated that the root cause for the its system down turned out to be a network hardware failure; the trunk fiber cable between the data switches failed.The fault was fixed by the hospital's biomed/ict staff the next day.The device remains at the customer site.No further investigation or action is warranted at this time.Additional information received indicating the fiber cables were determined to not be a philips product.Cross reference mfg report number 1218950-2022-00923.

Manufacturer Narrative

B5: additional information received indicating the fiber cables were determined to not be a philips product.

Manufacturer Narrative

Additional conclusion code.

• 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: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15519050
• MDR Text Key: 300986889
• Report Number: 1218950-2022-00904
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838048645
• UDI-Public: 00884838048645
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K153702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,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: PATIENT INFORMATION CENTER IX
• Device Catalogue Number: 866389
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/20/2022
• Initial Date FDA Received: 09/30/2022
• Supplement Dates Manufacturer Received: 09/20/2022; 09/20/2022; 09/20/2022
• Supplement Dates FDA Received: 11/09/2022; 11/18/2022; 12/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2016
• 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
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 77 KG