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

Model Number M8007A

Device Problem Device Alarm System (1012)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 01/27/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the user the patient's blood pressure dropped critically, but the monitor sent no alarm.The patient's blood pressure dropped critically.No further patient information was provided.

Manufacturer Narrative

A philips field service engineer (fse) went on site.The fse tested the monitor, and checked the alarm history.All alarms were triggered correctly.The reported issue was not able to be reproduced.The patient's blood pressure dropped critically.There was no patient harm, and no special treatment was necessary.The reported malfunction was not able to be reproduced; philips cannot rule out a malfunction at the time of the incident.The monitor alarming was unrelated to the drop in blood pressure and there was no adverse impact.A philips field service engineer provided instructions on how the borders and delta alerts are set, and how to adjust them; there is no remaining issue.The device remains at the customer site.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: betty harris ; 3000 minuteman road; andover, MA 01810
• MDR Report Key: 5418819
• MDR Text Key: 37741872
• Report Number: 9610816-2016-00047
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K021300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M8007A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2010
• 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