MAUDE Adverse Event Report: GE VINGMED ULTRASOUND AS P6D PROBE; ULTRASONIC DIAGNOSTIC TRANSDUCER

Lot Number 32L1253

Device Problems Nonstandard Device (1420); Failure to Align (2522); Output Problem (3005)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 05/13/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during a manufacturing process for acoustic power sample testing with a vivid e9 ultrasound system at a ge healthcare ultrasound manufacturing site in (b)(4), the measured acoustic output value (ispta.3) of a p6d probe was above the 720mw/cm^2 acoustic output limitation recorded in document 560 (information for manufacturers seeking marketing clearance of diagnostic ultrasound systems and transducers).The conclusion of the internal investigation associated with this issue discovered an off-axis misalignment of the measuring tool.Additionally, a method for detecting off-axis misalignment and re-calculation of the ispta.3 was found and applied to all probes that went through acoustic power testing within the timespan the measurement tool was misaligned.The results concluded 14 probes may fail to meet the 720mw/cm^2 acoustic output limitation; six fall within a maximum estimated ispta.3 of 757mw/cm^2, and eight fall within a maximum estimated ispta.3 of 1024mw/cm^2.Ge's investigation currently is continuing.

Manufacturer Narrative

Ge's investigation has completed.No systemic manufacturing process issue was found related to compliance with acoustic output guidelines and regulatory submissions.Probes in inventory that are under suspicion for ispta.3 > usl of 720mw/cm2 have been re-measured and dispositioned per manufacturing procedures.The issue is limited to a small number of probes, with small or moderate ispta deviations from expected values, combined with very low mi and low ti values.Ge's medical assessment concluded that biological effects are not reasonably expected, and thus it is concluded that field action is not required.

• Brand Name: P6D PROBE
• Type of Device: ULTRASONIC DIAGNOSTIC TRANSDUCER
• Manufacturer (Section D): GE VINGMED ULTRASOUND AS; strandpromenaden 45; horten N-319 1; NO N-3191
• MDR Report Key: 8691477
• MDR Text Key: 207716659
• Report Number: 9610482-2019-00001
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• PMA/PMN Number: K181685
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 32L1253
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1