MAUDE Adverse Event Report: GE HEALTHCARE AUSTRIA GMBH & CO OG IC9-RS; DIAGNOSTIC ULTRASOUND TRANSDUCER

Model Number H48691PJ

Device Problems Poor Quality Image (1408); No Apparent Adverse Event (3189)

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

Event Date 02/16/2024

Event Type  malfunction  

Manufacturer Narrative

Legal manufacturer: hcs kretz tiefenbach 15 austria zipf, oberosterreich, 4871.Ge healthcare reported a field modification for this ic9-rs double image malfunction per 21 cfr 806 on 29-dec-2023.The fda recall number is 8020021-12/29/23-001-c.Customers were sent a letter explaining the issue and requesting the customer to perform an inspection test to determine if the probe is malfunctioning.Ge healthcare has determined the cause of the malfunctioning probe to be a probe component.

Event Description

The customer performed an inspection test as part of correction and removal initiated by ge healthcare on 29-dec-2023 (recall no.8020021-12/29/23-001-c), and it was concluded the ic9-rs diagnostic ultrasound probe was identified as having a component malfunction described in recall no.8020021-12/29/23-001-c.There was no patient involvement.

Manufacturer Narrative

Correction - additional information was received reporting that the probe did not malfunction and is therefore not adverse event reportable.

• Brand Name: IC9-RS
• Type of Device: DIAGNOSTIC ULTRASOUND TRANSDUCER
• Manufacturer (Section D): GE HEALTHCARE AUSTRIA GMBH & CO OG; tiefenbach 15; zipf oberosterreich, 4871 ; AU 4871
• Manufacturer (Section G): GE HEALTHCARE AUSTRIA GMBH & CO OG; tiefenbach 15; zipf oberosterreich, 4871 ; AU 4871
• Manufacturer Contact: joseph tamblyn ; 9900 w innovation dr; mail drop: a1060; wauwatosa, WI 53226
• MDR Report Key: 18735548
• MDR Text Key: 336226326
• Report Number: 8020021-2024-00111
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00840682105026
• UDI-Public: 010084068210502611230817
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201828
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/11/2024

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: Health Professional
• Device Model Number: H48691PJ
• Device Lot Number: 1273976WX9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/16/2024
• Initial Date FDA Received: 02/19/2024
• Supplement Dates Manufacturer Received: 02/16/2024
• Supplement Dates FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Removal/Correction Number: 8020021-12/29/23-001-C
• Patient Sequence Number: 1