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

Model Number 866389

Device Problem Defective Alarm (1014)

Patient Problems Low Oxygen Saturation (2477); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/10/2023

Event Type  Death  

Event Description

The customer reported that a patient passed away on (b)(6) 2023 and they need to see if the monitor alarmed for the spo2.The customer biomedical engineer (biomed) verified the concern as a potential failure of monitor to alarm.A philips remote service engineer (rse) remotely accessed the philips patient information ix (pic ix) system and it showed the monitor comes online and the ecg alarms come on, but the spo2 does not show to come on.Follow-up with the customer found the clinical audit log indeed show spo2 on/off for the alarms.A philips technical consultant (tc) pulled clinical audit logs, pic ix logs, and device configuration and logs.Tc used simulators to generate both ecg and sp02 alarms on both monitor and central station using biomed surveillance.Further troubleshooting is expected.

Manufacturer Narrative

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

Manufacturer Narrative

The philips technical consultant (tc) pulled the clinical audit logs, pic ix logs, and device configuration and logs.The fse used simulators to generate both ecg and spo2 alarms on both the monitor and central station using biomedical surveillance.The pic ix appeared to alarm as expected.The complaint was escalated for technical investigation and the results indicate that the equipment was functioning properly and that alarms should have been heard at the pic ix.The provided logs were reviewed by a business unit product support engineer (pse).The pse reviewed the audit log, and on (b)(6) 2023 at 04:21, spo2 was turned on, but at 04:59, the ¿sensor off¿ inop was generated and then ended a few seconds later.A ¿sensor off¿ inoperative (inop) error means that the sensor is connected to the mx100 device, but not properly applied to the patient.Inops are technical alarms that indicate the monitor cannot measure or detect alarm conditions reliably.A ¿spo2 sensor off¿ inop interrupts monitoring and alarm generation.The measurement numeric is replaced with a ¿-?-¿, and the inop tone plays.There were multiple instances of the ¿sensor off¿ inop, meaning the connection of the sensor to the patient was not properly connected and the monitor was not able to generate alarms.At 04:59, there is indication of spo2 being low, which means that the alarm was generated at the pic ix.After the alarms sounded, there is an ¿acknowledge¿ from the bedside by the user.This acknowledges all active alarms by switching off audible alarm indicators and lamps; however, the visual alarm indicators remain while the alarm condition is active and are displayed at the monitor and the pic ix.The customer was concerned about the gap in clinical audit logs.The pse advised in the stardate logs, the 3s-mx14 device is shown as being associated to the patient and started monitoring at 04:21 before it was disassociated at around 05:31.A minute before at 04:19, there are shown to be network alerts from the access point (ap)/access point controllers (apcs), which could indicate an issue with the ap/apc itself, which could cause the wireless monitors to not respond properly until the patient is within a better coverage of the ap/apc range.If there is an issue with the apcs/aps, they have to be resolved first.After those have been resolved, the patient must be within network coverage.The cause of the gap in clinical audit logs could be either the apcs/aps and/or the network coverage of the patient.Based on the information available and the testing conducted, the device was functioning as intended and there is no malfunction on the device.The reported problem was not confirmed.No further action is necessary at this time.

• 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: 17854097
• MDR Text Key: 324728496
• Report Number: 1218950-2023-00719
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838093041
• UDI-Public: 00884838093041
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• 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?: Yes
• 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: 09/19/2023
• Initial Date FDA Received: 10/02/2023
• Supplement Dates Manufacturer Received: 09/19/2023
• Supplement Dates FDA Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2020
• 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