MAUDE Adverse Event Report: DJO LLC INTELECT TRANSPORT COMBO PKG US STDAPPL; STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT

Model Number 2738

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 11/12/2021

Event Type  malfunction  

Event Description

It was reported that the device allegedly experienced a spiking intensity and then stopped working.

Manufacturer Narrative

It was reported that the device allegedly experienced a spiking intensity and then stopped working.There was no reported patient consequence or adverse event.The product has been received, but the investigation has not begun.Djo will provide a supplemental once the investigation is complete.

• Brand Name: INTELECT TRANSPORT COMBO PKG US STDAPPL
• Type of Device: STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
• Manufacturer (Section D): DJO LLC; 5919 sea otter place; suite 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; carlsbad; vista, CA 92010 ; 5128346301
• MDR Report Key: 12973125
• MDR Text Key: 283597309
• Report Number: 9616086-2021-00017
• Device Sequence Number: 1
• Product Code: IMG
• UDI-Device Identifier: 00888912021883
• UDI-Public: 00888912021883
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 12/09/2021

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: 2738
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2021
• Initial Date FDA Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: No
• 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