MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS ST8OI STRESS TEST SYSTEM; PHILIPS ST8OI STRESS TEST SYSTEM

Model Number 860343

Device Problem Self-Activation or Keying (1557)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Date 06/09/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported that a patient was beginning a stress test, got tired and was put in a chair, on the treadmill.While the patient was resting, the treadmill started unexpectedly and the patient fell off the treadmill.The patient suffered bruising and was kept overnight at the hospital for pain management.Multiple tests (catscan, x-ray) were conducted and no prolonged care was required.The patient went home the next day.

Manufacturer Narrative

And over product support and engineering attempted to duplicate the customer issue without success.This complaint has been evaluated and does not allege a death or prolonged injury.The hospital conducted their own investigation into the issue and a philips field service engineer visited the site on (b)(6) 2016 to evaluate the device.The philips fse was not able to reproduce the issue.The hospital agrees that the issue cannot occur without user interaction.The scenario reported by the customer is not possible on the st80i without a user reactivating the system on the device.The customer was also advised not to put a patient in a chair on the treadmill as a best use practice.No malfunction of the device / treadmill could be found.The device remains at the customer site.There have been no additional calls from the customer to report the same failure.This issue has never been reported to philips prior or since this occurrence.

• Brand Name: ST8OI STRESS TEST SYSTEM
• Type of Device: PHILIPS ST8OI STRESS TEST SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: robert corning ; 3000 minuteman road; andover, MA 01810
• MDR Report Key: 5738258
• MDR Text Key: 47824617
• Report Number: 1218950-2016-03650
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Model Number: 860343
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/09/2016
• Initial Date FDA Received: 06/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2014
• 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
• Patient Age: 65 YR