MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MP50 INTELLIVUE PATIENT MONITOR; COMPACT PATIENT MONITOR

Model Number M8004A

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Patient Problem/Medical Problem (2688)

Event Date 11/11/2018

Event Type  Death  

Manufacturer Narrative

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

Event Description

The customer reported that alarms were possibly turned off.The patient coded and passed away.

Manufacturer Narrative

There was no product malfunction.A philips field service engineer (fse) retrieved the alarm audit logs from the central station, and sent the information to a philips complaint investigator (ci).The ci reviewed the logs, and spoke to the customer nurse manager.The ci informed the nurse manager that the logs show that the spo2 alarms were turned off for icu14 at the bedside on (b)(6) 2018 at 19:35 and not turned back on until (b)(6) 2018 at 16:01.The patient code had occurred at approximately 15:54 on (b)(6) 2018; the patient survived the code, and passed away the next day.The alarm audit logs show multiple spo2 alarms occurred leading up to the spo2 alarms being turned off.Information regarding the alarms being turned off was provided to the customer.The device remains at the customer site.No further investigation is warranted at this time.

• Brand Name: MP50 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: 8089214
• MDR Text Key: 127882630
• Report Number: 9610816-2018-00319
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/13/2018

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: M8004A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/13/2018
• Initial Date FDA Received: 11/20/2018
• Supplement Dates Manufacturer Received: 11/13/2018
• Supplement Dates FDA Received: 12/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2004
• 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
• Patient Age: 58 YR