MAUDE Adverse Event Report: DJO LLC AIRCAST; VENAFLOW ELITE SYSTEM, WITH S-MODE

Catalog Number	30B-S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	10/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that unit was plugged in, the unit was not on the patient.The nurse was cleaning it with a wipe and it started heating up and then she saw a spark on the venaflow and then the electrical shock was caused.The incident happened at 10 pm on (b)(6) 2024, we were notified on november 11 2024 at 11:46 pst.The nurse was treated, she was taken to the emergency room.
Additional Manufacturer Narrative
It was reported that unit was plugged in, the unit was not on the patient.The nurse was cleaning it with a wipe and it started heating up and then she saw a spark on the venaflow and then the electrical shock was caused.The incident happened at 10 pm on (b)(6) 2024, we were notified on november 11 2024 at 11:46 pst.The nurse was treated, she was taken to the emergency room.It was reported the nurse is alright, the treatment that was provided in the emergency room was not reported.The device has not been returned for evaluation.The root cause of the complaint could not be established.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: AIRCAST
• Common Device Name: VENAFLOW ELITE SYSTEM, WITH S-MODE
• Manufacturer (Section D): DJO LLC; 5919 sea otter place; ste 200; carlsbad CA 92010
• Manufacturer (Section G): DJO; 3151 scott st.; vista CA 92081
• Manufacturer Contact: jim pomeroy ; 5919 sea otter place; ste 200; carlsbad, CA 92010
• MDR Report Key: 20872493
• Report Number: 9616086-2024-00124
• Device Sequence Number: 15416714
• Product Code: JOW
• UDI-Device Identifier: 00888912306553
• UDI-Public: 00888912306553
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K130722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 30B-S
• Device Lot Number: E78376
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown