MP5 M8105A (865024)

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-25 for MP5 M8105A (865024) manufactured by Philips Medical Systems.

Event Text Entries

[125279351] (b)(6). A follow up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10

[125279352] The customer reported that "there is no alarm sound at spo2's lower limit measurement. No adverse event involving patient or user was reported.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9610816-2018-00291
• MDR Report Key: 8004926
• Date Received: 2018-10-25
• Date of Report: 2018-09-27
• Date Mfgr Received: 2018-09-27
• Device Manufacturer Date: 2009-02-17
• Date Added to Maude: 2018-10-25
• 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
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS. BETTY HARRIS
• Manufacturer Street: HEWLETT-PACKARD STR.2
• Manufacturer City: BOEBLINGEN 71034
• Manufacturer Country: GM
• Manufacturer Postal: 71034
• Manufacturer G1: PHILIPS MEDICAL SYSTEMS
• Manufacturer Street: 3000 MINUTEMAN ROAD
• Manufacturer City: ANDOVER MA 01810
• Manufacturer Country: US
• Manufacturer Postal Code: 01810
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: MP5
• Generic Name: PATIENT MONITOR
• Product Code: BZQ
• Date Received: 2018-10-25
• Model Number: M8105A (865024)
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: R
• 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		2018-10-25