MAUDE Adverse Event Report: CRITIKON DE MEXICO S. DE R.L. DE C.V. VENUE GO; DIAGNOSTIC ULTRASOUND SYSTEM

Model Number H45051PB (CABLE)

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

No report of patient involvement.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

Gehc received a report from a customer that the user was removing the venue go power cord from the system when the cable of the female-end/system-end of the venue go power cord separated from the plug exposing electrically energized wires.No injury occurred.The damaged cable was disposed by the customer and is unavailable for evaluation.

Manufacturer Narrative

Gehc's investigation has completed.The customer provided photos of the damaged power cord which were assessed by gehc and the manufacturer of the power cord.Additionally, the manufacturer of the power cord evaluated production material and processes as part of the investigation.The conclusion was that power cord manufacturer production processes and raw materials are within specifications and there is no indication these would have contributed to the failure of the power cord.Thus the most likely cause is stress damage from pulling, bending, blows and/or smashing to the strain relief & cable while in the potentially chaotic emergency room environment the system is in.The issue was corrected by replacing the damaged power cord upon failure.Gehc's risk assessment concluded that mitigations in place are sufficient and at an acceptable level, and no further actions are required at this time.

• Brand Name: VENUE GO
• Type of Device: DIAGNOSTIC ULTRASOUND SYSTEM
• Manufacturer (Section D): CRITIKON DE MEXICO S. DE R.L. DE C.V.; calle valle del cedro 1551; juarez 32575 ; MX 32575
• Manufacturer (Section G): CRITIKON DE MEXICO S. DE R.L. DE C.V.; calle valle del cedro 1551; juarez 32575 ; MX 32575
• Manufacturer Contact: joseph tamblyn ; 9900 w innovation dr; mal drop: rp-2130 / b4422; wauwatosa, WI 53226-4856
• MDR Report Key: 15198687
• MDR Text Key: 302717221
• Report Number: 3008729547-2022-00005
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K183362
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H45051PB (CABLE)
• Device Lot Number: VGB000326
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1