MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC PHILIPS ST80I STRESS TEST SYSTEM

Model Number 860343

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/20/2022

Event Type  Injury  

Event Description

The customer reported that they¿ve gone to switch it on the device with a patient in situ, and the belt has thrown this person backwards and treadmill gone into reverse.The patient is harmed.Additional information has been requested.

Manufacturer Narrative

Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

Manufacturer Narrative

Based on the information available and results of additional analysis by the rse, with confirmation from the manufacturer, the treadmill does not go in reverse.The customer has been instructed not to start treadmill while the patient is standing on it, per the ifu.The investigation identified no design issue or malfunction.The device remained and use with precaution instructions.

• Brand Name: PHILIPS ST80I STRESS TEST SYSTEM
• Type of Device: PHILIPS ST80I STRESS TEST SYSTEM
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16194404
• MDR Text Key: 307577934
• Report Number: 1218950-2023-00033
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 00884838094840
• UDI-Public: 00884838094840
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K121638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 860343
• Device Catalogue Number: 860343
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/28/2016
• 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): Other