MAUDE Adverse Event Report: DJO LLC INTELECT TRANSPORT 2CH STIM US STD; STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT

Model Number	2783
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	01/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the intensity allegedly increases a lot even when increasing slowly.It was reported the unit allegedly shocked the patient when the physical therapist (pt) pushed intensity button for 1 second and the unit went from 0-45v.The patient was not injured only surprised.
Additional Manufacturer Narrative
It was reported that the intensity allegedly increases a lot even when increasing slowly.It was reported the unit allegedly shocked the patient when the physical therapist (pt) pushed intensity button for 1 second and the unit went from 0-45v.The patient was not injured only surprised.The product has not been received.Djo will provide a supplemental if the product is returned for evaluation.

• Brand Name: INTELECT TRANSPORT 2CH STIM US STD
• Common Device Name: STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
• Manufacturer (Section D): DJO LLC; 5919 sea otter place; ste 200; carlsbad CA 92010
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 parque industrial el flo; tijuana, b.c. 22245 ; MX 22245
• Manufacturer Contact: jim pomeroy ; 5919 sea otter place; ste 200; carlsbad, CA 92010
• MDR Report Key: 13500793
• Report Number: 9616086-2022-00002
• Device Sequence Number: 14674118
• Product Code: IMG
• UDI-Device Identifier: 00888912293945
• UDI-Public: 00888912293945
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K040285
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/09/2022

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
• Operator of Device: Health Professional
• Device Model Number: 2783
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown