STRESSVUE 860295

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-01-06 for STRESSVUE 860295 manufactured by Philips Medical Systems.

Event Text Entries

[178338560] Unable to confirm serial number. A follow-up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10

[178338561] Customer reported that when the emergency button was depressed, the treadmill speed increased. The device was in use on a patient. There was no report of patient or user harm.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1218950-2020-00104
• MDR Report Key: 9555015
• Report Source: HEALTH PROFESSIONAL,USER FACI
• Date Received: 2020-01-06
• Date of Report: 2020-01-03
• Date Mfgr Received: 2020-01-03
• Date Added to Maude: 2020-01-06
• 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: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. ROBERT CORNING
• Manufacturer Street: 3000 MINUTEMAN ROAD
• Manufacturer City: ANDOVER MA 01810
• Manufacturer Country: US
• Manufacturer Postal: 01810
• Manufacturer Phone: 9786871501
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: STRESSVUE
• Generic Name: NA
• Product Code: DPS
• Date Received: 2020-01-06
• Model Number: 860295
• 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: 3000 MINUTEMAN ROAD ANDOVER MA 01810 US 01810

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-01-06