MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. EC9-4 TRANSDUCER; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number 10041225

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/23/2017

Event Type  malfunction  

Event Description

The probe was given to the biomed department to repair cracked housing on the connector side.

• Brand Name: EC9-4 TRANSDUCER
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 22010 s.e. 51st st.; issaquah WA 98029
• MDR Report Key: 6878613
• MDR Text Key: 86751509
• Report Number: 6878613
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/23/2017,08/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 10041225
• Device Lot Number: C4553580
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/23/2017
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/23/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: N.A.