MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC PERCUNAV SYSTEM; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 795084

Device Problem Unintended Movement (3026)

Patient Problem Injury (2348)

Event Date 04/27/2015

Event Type  Injury  

Manufacturer Narrative

Our investigation concluded there was no device malfunction.The application specialist did not follow the appropriate installation protocol as documented in the service manual for this device.

Event Description

A philips clinical applications specialist was injured during installation of a percunav system.The spring arm on the field generator pole sprang upward striking the application specialist on the nose causing a small cut.A bandage was issued to treat the application specialist and no additional medical intervention was required.No additional patients or users were involved in this event.

• Brand Name: PERCUNAV SYSTEM
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: paul corrigan ; 22100 bothell everett highway; bothell, WA 98021 ; 4254877000
• MDR Report Key: 6665346
• MDR Text Key: 78343633
• Report Number: 3019216-2017-00021
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: LH
• PMA/PMN Number: K132087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial
• Report Date: 04/27/2015

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: Medical Equipment Company Technician/Representative
• Device Model Number: 795084
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/27/2015
• Initial Date FDA Received: 06/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other