MP5 M8105A (865024)

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-10-05 for MP5 M8105A (865024) manufactured by Philips Medical Systems.

Event Text Entries

[122886413] A follow up report will be submitted once the investigation is complete. Patient information requested not available at time of report.
Patient Sequence No: 1, Text Type: N, H10

[122886414] Patient was being monitored with a mx40 tele box, nurse used an mp5 to take the patient? S blood pressure then turned off the mp5 and assumed the patient was still being monitored by the mx40. The patient was no longer being monitored by the mx40 or the mp5 and expired while not being monitored.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9610816-2018-00247
• MDR Report Key: 7938066
• Report Source: USER FACILITY
• Date Received: 2018-10-05
• Date of Report: 2018-09-07
• Date of Event: 2018-07-07
• Date Mfgr Received: 2018-09-07
• Device Manufacturer Date: 2015-03-26
• Date Added to Maude: 2018-10-05
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: BIOMEDICAL ENGINEER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MP5
• Generic Name: PATIENT MONITOR
• Product Code: BZQ
• Date Received: 2018-10-05
• Model Number: M8105A (865024)
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PHILIPS MEDICAL SYSTEMS
• Manufacturer Address: HEWLETT-PACKARD STR.2 BOEBLINGEN 71034 GM 71034

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2018-10-05