MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MX500 PATIENT MONITOR

Model Number 866064

Device Problem Component Missing (2306)

Patient Problems Tissue Damage (2104); Low Oxygen Saturation (2477)

Event Date 01/28/2020

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

The customer reported that on (b)(6) 2020 around 12:32, a patient removed his spo2 sensor and his oxygen supply and no "spo2 sensor off" inop was announced according to the clinical staff.The spo2 saturation of the male patient dropped to 23 %, causing possible damage to heart and brain.The patient was moved to a ward with higher level care.No further details regarding the patient, such as age, height, and weight were made available.

Manufacturer Narrative

A philips field service engineer (fse) went onsite to collect the central station audit logs, the trend review, and the alarm review from the intellivue mx500 patient monitor.The obtained logs were reviewed by the fse and a philips remote application specialist (ras).The patient removed his spo2 sensor and oxygen supply at 12:32:45.Using the general review trends and compressed waves, it was verified that the pleth wave, spo2, and pulse values were displayed until 12:32:46.At 12:32:46, the bedside monitor alarmed for "spo2 sensor off" per the alarm review obtained from the bedside monitor.This "spo2 sensor off" alarm was silenced at the central station at 12:32.58 per the central station audit log.When the patient's wife returned 15 minutes later, she noticed that the patient was blue.The spo2 sensor was replaced onto the patient at 12.46:37 and the monitor alarmed for a low spo2 level of 23 %.The customer was advised of the investigation outcome by the fse.The device worked as intended and there was no malfunction of the device.This issue was caused by user error.No further investigation or action is warranted.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: INTELLIVUE MX500 PATIENT MONITOR
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 9664193
• MDR Text Key: 177544249
• Report Number: 9610816-2020-00041
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K131872
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/28/2020

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: 866064
• Device Catalogue Number: 866064
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/28/2020
• Initial Date FDA Received: 02/04/2020
• Supplement Dates Manufacturer Received: 01/28/2020
• Supplement Dates FDA Received: 07/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention