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

Model Number M8007A

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that a patient has experienced asystole.On the monitor there was something else to be seen.The device was in use during monitoring a patient.There was no information regarding the serious injury.

Manufacturer Narrative

At the time of the alleged malfunction, the device was being used for clinical monitoring.The patient did not require resuscitation or other emergent care as a result of this lengthy pause event therefore the event was not consistent with a serious injury.No malfunction occurred.The patient had a lengthy pause event for which an asystole alarm was expected but only a pair pvc alarm was provided.The issue represents an application issue in that the lead chosen for monitoring had some p-waves which were tall enough to be detected as beats, thereby preventing the system from meeting the alarm criteria for an asystole event.Product labeling adequately describes how to choose an optimal lead for accurate arrhythmia monitoring.

Event Description

The customer reported that a ¿pair pvcs¿ alarm was provided for a patient at a time when a asystole alarm was expected.The issue occurred on (b)(6) 2016 at around 23:23.No patient harm was reported.

• 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: wendy chadbourne ; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 5413260
• MDR Text Key: 37558837
• Report Number: 9610816-2016-00045
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2016
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2009
• 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