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

Model Number M8007A

Device Problems Device Alarm System (1012); Defective Alarm (1014); No Audible Alarm (1019)

Patient Problem Tachycardia (2095)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A clinical user at the customer site stated that on (b)(6) 2019 around the 10:00am timeframe, the patient' (in bed# icu 316) heart rate (hr) when up above 120 bpm, and the monitor did not trigger an audio or visual yellow high hr alarm.They claimed that at random times, the yellow hr alarm will announce, the yellow hr banner remains on the screen (even though the patient condition does not correct), but there was no audio tone, even after the time-out period.No adverse event or patient harm was reported.

Manufacturer Narrative

Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• 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
• MDR Report Key: 8431561
• MDR Text Key: 139425809
• Report Number: 9610816-2019-00075
• Device Sequence Number: 0
• Product Code: DSI
• PMA/PMN Number: K021300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/27/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M8007A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 68