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

Model Number M8007A

Device Problem Defective Alarm (1014)

Patient Problem Death (1802)

Event Date 05/31/2018

Event Type  Death  

Manufacturer Narrative

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

Event Description

The customer reported that the alarm did not go off on the monitor.The patient died.

Manufacturer Narrative

A philips complaint investigator (ci) attempted to obtain further information on this case.Despite several attempts to obtain additional information, no further details were provided.With the available information, philips has not been able to establish exactly what happened at the time of the reported event, and therefore it was not possible to establish a clear cause.Philips cannot rule out a malfunction of the device.Attempts to obtain information have been unsuccessful.No parts have been ordered and no repair was found to be initiated.We will consider that the customer resolved the issue and that the device remains in use at the customer site, as no subsequent calls have been logged from this customer for this type of device/issue.No further investigation or action is warranted at this time.Patient information has been requested, not available by customer.

• 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: 7581789
• MDR Text Key: 110458599
• Report Number: 9610816-2018-00138
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 05/31/2018

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?: 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: 06/01/2018
• Initial Date FDA Received: 06/08/2018
• Supplement Dates Manufacturer Received: 06/01/2018
• Supplement Dates FDA Received: 08/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2008
• 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