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

Model Number M8007A

Device Problem Device Alarm System (1012)

Patient Problem Cardiopulmonary Arrest (1765)

Event Date 01/21/2015

Event Type  Injury  

Manufacturer Narrative

According to the field service engineer (fse), the device did not malfunction, there was a configuration issue.Their device was re-configured for the alarm reminders to alarm every 2 minutes.Walked customer through profile changing.Tested result.The issue has been resolved, by confirming to the customer that the device did not malfunction.It was confirmed that the alarm had sounded, been silenced and did not re-alarm before patient coded.Alarm was leads off, so patient was not monitored.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.Since there was no identified malfunction of the device, no patient characteristics are needed.None will be pursued.

Event Description

The customer called to discuss how to change profile to allow re-alarm at two minute interval.He said that alarm had sounded, been silenced and did not re-alarm before patient coded.Alarm was leads off, so patient was not monitored.This is being reported as a serious injury.It was reported that the patient coded but did not expire.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: 6328985
• MDR Text Key: 67373874
• Report Number: 9610816-2017-00039
• 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: Other
• Type of Report: Initial
• Report Date: 01/21/2015

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/21/2015
• 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