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

Model Number M8007A

Device Problems Failure to Read Input Signal (1581); Device Displays Incorrect Message (2591)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802)

Event Date 11/19/2014

Event Type  Death  

Manufacturer Narrative

According to the philips fse, who was onsite, the mp70 was revision h and the mms had revision e.01.It was confirmed that there was a sw incompatibility.It was confirmed that the device did provide an inop along with spo2 alarms to alert the staff the issue has been resolved by upgrading the sw and the device is working as expected.The device remains at the customer site.The customer's reported issue is resolved, and no further calls or complaints have been documented regarding this issue.The evaluation outcome of the investigation is that there was no product malfunction.The whole device/system remains at the customer site.The troubleshooting that has already been done by the customers biomed is considered as all that is warranted for the customer's reported issue.The available information supports that there is no design, manufacturing, materials, or labeling problem.No further investigation or action is warranted.

Event Description

The customer stated that the mp70 lost the bp keys and showed an inop "mms unsupported".This is being reported as a death.The patient was in full arrest status and cpr was unsuccessful.No further information is available.

• 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: nancy ataide ; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 6328991
• MDR Text Key: 67370270
• Report Number: 9610816-2017-00040
• 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: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event 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: 11/20/2014
• Initial Date FDA Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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