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

Model Number 866389

Device Problem Defective Alarm (1014)

Patient Problem Brain Injury (2219)

Event Date 03/05/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer biomedical engineer (biomed) reported the clinical staff said that on (b)(6)2024 at approximately 19:00, a 67 year old female patient weighing 70 kg, height is 1.68 m, in rm #234, on the m2 telemetry unit failed to alarm for a desaturation (desat) of 85%; the clinical staff did not hear an alarm.The patient was wearing a mx40 connected to the picix.The patient developed an anoxic brain injury due to the failure to alarm for spo2 desat.

Manufacturer Narrative

A philips clinical product specialist reviewed the information provided.Based on the information provided the following determination was made.A review of the clinical audit logs revealed many spo2t inoperative (inop) technical alarms occurred for several hours leading up to the event timeframe.Inop alarms included spo2 no pulse, ecg leads off, tele weak signal, leadset unplugged, and noisysignal.Spo2 inops interrupted monitoring but when the value was present it was reported to be within the alarm limit range and therefore did not generate a physiological alarm.The alarms were on and set to 90 and 100 with desat limit of 88.There were no physiological spo2 alarms visible in the audit log during the stated time frame.It was also noted, based on the pictures provided by the visiting support engineer, that non-philips leadsets may be being used.The leadsets shown have not been validated for use with the philips mx40 device.Based on the information available and the testing conducted, the cause of the reported problem was not confirmed.Based on the information provided, there is no indication that the pic ix was not functioning as intended.The audit logs indicated that spo2 inops interrupted monitoring but when the value was present it was reported to be within the alarm limit range and therefore did not generate a physiological alarm.It was also noted, based on the pictures provided by the visiting support engineer, that non-philips leadsets may be being used.The leadsets shown have not been validated for use with the philips mx40 device.The investigation concludes that no further action is required 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: 18901864
• MDR Text Key: 337626583
• Report Number: 1218950-2024-00191
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/22/2021
• 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): Life Threatening
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 70 KG