MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS STRESSVUE

Model Number 860295

Device Problem Malposition of Device (2616)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Customer reported that when the emergency button was depressed, the treadmill speed increased.There was no patient harm or injury reported.

• Brand Name: STRESSVUE
• Type of Device: NA
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: betty harris ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 9324616
• MDR Text Key: 174316451
• Report Number: 1218950-2019-08670
• Device Sequence Number: 1
• Product Code: DPS
• UDI-Device Identifier: 00884838058729
• UDI-Public: (01)00884838058729
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 860295
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/08/2019
• Initial Date FDA Received: 11/14/2019
• Supplement Dates Manufacturer Received: 11/08/2019
• Supplement Dates FDA Received: 01/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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