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

Device Problem Output Problem (3005)

Patient Problem Electric Shock (2554)

Event Date 01/28/2022

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 290062675
• Report Number: 9616086-2022-00002
• Device Sequence Number: 1
• Product Code: IMG
• UDI-Device Identifier: 00888912293945
• UDI-Public: 00888912293945
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2783
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1