MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MP40 INTELLIVUE PATIENT MONITOR; COMPACT PATIENT MONITOR

Model Number M8003A

Device Problems Device Alarm System (1012); Loss of Power (1475)

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 nurse reported that the monitor did not alarm.The nurse said when the patient's heart rate was fast, the monitor did not announce an alarm; the monitor alarm sound and alarm light lasted only 3-4 seconds and then turned off.The device was in clinical use at the time the issue was discovered.No death or patient /user injury or harm was reported.The patient was noted to be fine.No patient details were provided.

• Brand Name: MP40 INTELLIVUE PATIENT MONITOR
• Type of Device: COMPACT 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: 7159636
• MDR Text Key: 96380455
• Report Number: 9610816-2018-00002
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K030038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M8003A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 01/03/2018
• Supplement Dates Manufacturer Received: 12/07/2017
• Supplement Dates FDA Received: 06/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2011
• 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