MAUDE Adverse Event Report: BK MEDICAL APS ENDOCAVITY BIPLANE TRANSDUCER; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number 8848

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2020

Event Type  malfunction  

Event Description

Ultrasound scanner 1202 not working.

Event Description

Ultrasound scanner 1202 not working.The or said there was no error code.When the probe was attached to the ultrasound machine, there was no image.

• Brand Name: ENDOCAVITY BIPLANE TRANSDUCER
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): BK MEDICAL APS; 8 centennial dr; peabody MA 01960
• MDR Report Key: 10894129
• MDR Text Key: 217948392
• Report Number: 10894129
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 11/19/2020

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: Other
• Device Model Number: 8848
• Device Catalogue Number: 8848
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/19/2020
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/24/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/24/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 24820 DA
• Patient Weight: 106