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

Model Number M8007A

Device Problem Data Problem (3196)

Patient Problem Death (1802)

Event Date 08/25/2017

Event Type  Death  

Manufacturer Narrative

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

Event Description

The customer reported that there was an incident with a patient and they want to investigate.They are asking for the error logs to be interpreted.Further information received form the customer indicated that the patient arrived with chest pain.There was a delay with doing an ecg to rule out myocardial infarction.There is question whether st elevation was captured on arrival and if so, was there an alarm indicating same; they think the bedside alarm would go off if this was the case.The customer indicated it is possible with an early alert from the monitor it might have expedited the action, if performing a 15 lead ecg.The device was in clinical use at the time the issue was discovered.The patient was noted to have died within hours of arrival.

Manufacturer Narrative

The customer indicated that the patient arrived with chest pain, and that there was a delay with doing an ecg to rule out myocardial infarction.They were questioning whether st elevation was captured on arrival and if so, was there an alarm indicating same; they think the bedside alarm would have gone off if this was the case.An attempt was made to obtain alarm logs from the central station and screen shots from the patient monitor.However, it was explained that this event occurred on (b)(6) 2017.The customer is using the intellivue piic classic for a central station, which for this customer only holds 24 hours of data.The bedside monitor also can only hold data for a limited amount of time.Due to this, no alarm logs, or screen shots from the bedside monitor were available for review.As this information was not available, it could not be determined if an alarm had, or had not been activated for a possible increase in st elevation.It could also not be verified if the patient had experienced a st elevation.A product malfunction could not be ruled out.The device remains at the customer site, and no subsequent calls have been logged for this device/issue.No further investigation is warranted at this time.

• 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: richa shah ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 7261365
• MDR Text Key: 99767424
• Report Number: 9610816-2018-00044
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K021300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/31/2018

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?: No
• 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: 01/31/2018
• Initial Date FDA Received: 02/09/2018
• Supplement Dates Manufacturer Received: 01/31/2018
• Supplement Dates FDA Received: 04/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2009
• 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; Required Intervention
• Patient Age: 48 YR