MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MP70 INTELLIVUE PATIENT MONITOR

Model Number M8007A

Device Problem Device Alarm System (1012)

Patient Problem Death (1802)

Event Date 10/30/2018

Event Type  Death  

Manufacturer Narrative

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

Event Description

The customer called with concerns over spo2 alarms and configuration due to a patient death in room (b)(6) on (b)(6) 2018 at 11:06am.

Manufacturer Narrative

No device malfunction occurred.The findings were presented to the customer.The customer will be working with their philips account manager and regional service manager to review their system setup.Review of those logs and screen shots indicated that two (2) sources of spo2 were available during the incident: spo2 and spo2l.According to screen shots, ¿sp02l¿ was the source being used for the patient and ¿sp02l¿ alarms had been turned off on (b)(6) at 23:35 and had remained off until (b)(6), 16:57, after the patient event.For the second source, sp02, alarms were noted to be ¿on¿ at 08:56 on (b)(6), but this was not relevant for the patient at the time of the event because this spo2 source was not being used.This is considered a user misunderstanding of spo2 source and configuration.

• Brand Name: MP70 INTELLIVUE PATIENT MONITOR
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: betty harris ; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 8046659
• MDR Text Key: 126410249
• Report Number: 9610816-2018-00309
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/30/2018

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: M8007A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/30/2018
• Initial Date FDA Received: 11/07/2018
• Supplement Dates Manufacturer Received: 10/30/2018
• Supplement Dates FDA Received: 11/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2008
• 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: 76 YR