MAUDE Adverse Event Report: DYMAX CORP. SITE~RITE 8 BRAZIL; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Catalog Number 9770552

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem Complaint, Ill-Defined (2331)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer, at this time, for evaluation.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.

Event Description

It was reported that during the insertion of a picc catheter in an adult patient, exactly at the moment of puncture, the display freezed, it turned black and has not turned on anymore.It was plugged in electrical web and it was charging at the time.It was further reported that some procedures were performed in an attempt to turn it on, but unsuccessful.The needle was already inserted into the patient's skin, therefore there was patient impact.It was necessary to pick another equipment to complete the procedure.It was reported that the display does not turn on, but the battery light keeps flashing in green.

• Brand Name: SITE~RITE 8 BRAZIL
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): DYMAX CORP.; 141 zehner school road; zelienople PA 16063
• Manufacturer (Section G): DYMAX CORP.; 141 zehner school road; zelienople PA 16063
• Manufacturer Contact: sydney freckleton ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225992
• MDR Report Key: 8972886
• MDR Text Key: 156906764
• Report Number: 3006260740-2019-02630
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741098093
• UDI-Public: (01)00801741098093
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K152554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9770552
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Date Manufacturer Received: 08/12/2019
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 69 YR