MAUDE Adverse Event Report: GE VINGMED ULTRASOUND AS P6D PENCIL PROBES; DOPPLER ULTRASOUND PROBE

Model Number TQ100002

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

Patient information is not applicable.Probe serial numbers are (b)(4).The initial reporter is internal to ge, and there is no external customer reporting this.The seven probes have a manufacturing date range between late-may to mid-june of 2015.

Event Description

On 25-nov2015 ge personnel discovered that 47 p6d probes manufactured from the period of april-2015 to november-2015 had been shipped to various customers around the globe without being tested for conformance to acoustic output power specifications (fda limitation: 720mw/cm^2), and seven of the 47 were shipped to customers within the usa.Ge has re-instated 100% acoustic output testing since 26-nov2015 due to the possibility probes may exceed specifications, and this method prevents defective probes from being shipped to customers.Investigation of the issue has shown that incoming testing/inspections for these probes were being performed until april-2015, and they were inadvertently stopped because of a change in routing from the supplier.Incoming testing/inspections were resumed in november-2015 and since then sixteen of 270 p6d probes undergoing testing/inspections failed to meet specifications and were prevented from shipping to customers, thus confirming the process effectiveness.Additionally, no other probes have been found to be defective, and the installed base data was reviewed and there were no reports of p6d probes with heating issues.

• Brand Name: P6D PENCIL PROBES
• Type of Device: DOPPLER ULTRASOUND PROBE
• Manufacturer (Section D): GE VINGMED ULTRASOUND AS; strandpromenaden 45; horten ; NO
• Manufacturer Contact: joseph tamblyn ; mail drop: rp-2138; 9900 w. innovation dr.; wauwatosa, WI
• MDR Report Key: 6312268
• MDR Text Key: 67234541
• Report Number: 9610482-2017-00002
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• PMA/PMN Number: K150087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 11/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TQ100002
• Other Device ID Number: UDI_NOT_REQUIRED
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/1970
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1