MAUDE Adverse Event Report: GE VINGMED ULTRASOUND AS 6VT-D PROBE WITH VIVID E9; ULTRASOUND TRANSDUCER

Lot Number 210339

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation of Esophagus (2399)

Event Date 05/27/2021

Event Type  Death  

Manufacturer Narrative

Patient information could not be obtained due to country privacy laws.Udi: (b)(4).The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Legal manufacturer: (b)(4).

Event Description

The customer reported that a patient examined on (b)(6) 2021 with 6vt-d (sn (b)(4)) probe with vivid e95 (sn (b)(4)) was evaluated via a ct thorax exam post tee and was diagnosed with pneumomediastinum (esophageal perforation - ep), a severe complication of tee, and died a day after the tee exam ((b)(6) 2021).At the time the customer did not suspect any probe malfunctions contributed to the ep.At a later date, and retrospectively, the customer asked gehc to evaluate the 6vt-d probe for sharp edges.Gehc evaluated the probe, concluding the 6vt-d probe did not malfunction nor did it have surface defects that would have caused or contributed to the ep.Gehc believes that the ep the patient suffered to be a severe complication of a tee examination, which is a well-known potential risk of tee examinations.Gehc is monitoring ep as a result of tee for trends.At this time gehc has no further actions planned.

• Brand Name: 6VT-D PROBE WITH VIVID E9
• Type of Device: ULTRASOUND TRANSDUCER
• Manufacturer (Section D): GE VINGMED ULTRASOUND AS; strandpromenaden 45; horten N-319 1; NO N-3191
• Manufacturer (Section G): GE VINGMED ULTRASOUND AS; strandpromenaden 45; horten N-319 1; NO N-3191
• Manufacturer Contact: joseph tamblyn ; 9900 w. innovation dr.; mail drop: rp-2130 / b4422; wauwatosa, WI 53226-4856
• MDR Report Key: 12071686
• MDR Text Key: 258520606
• Report Number: 9610482-2021-00003
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• PMA/PMN Number: K141093
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial
• Report Date: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 210339
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2017
• 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