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

Model Number M8007A

Device Problem No Flow (2991)

Patient Problem Death (1802)

Event Date 03/18/2018

Event Type  Death  

Manufacturer Narrative

There was no malfunction of the device.A philips response center engineer (rce) spoke to the customer, and found no issues with the device; the monitor alarmed as expected.The monitor displayed the patient perfusion index (perf) =.18, which is not acceptable; therefore, the monitor produced an inop message ¿low perfusion¿.The clinical user had replaced the sensor and cable, but problem continued.The rce explained that questionable/ interpretable values will not flow over to epic; in this case the patient pleth wave very small (patient very sick perf value =.18).The rce recommended that the user change the spo2 sensor site/location, and then test with a portable monitor to confirm.We will consider that the customer resolved the issue using the information provided by the rce, and that the device remains in use at the customer site, as no subsequent calls have been logged for this device/issue.No further investigation or action is warranted at this time.Patient information has been requested and not available at the time of report.

Event Description

The customer reported that spo2 is not going through to the epiq, but all of the other vitals are, and also the patient is coding.The patient died.

• 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: 7435867
• MDR Text Key: 105660804
• Report Number: 9610816-2018-00094
• 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
• Report Date: 03/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• 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
• Date Manufacturer Received: 03/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2006
• 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