MAUDE Adverse Event Report: DJO, LLC AIRCAST; PACK, HOT OR COLD, WATER CIRCULATING

Model Number	51A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	03/24/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Complaint received that alleges "motor will not turn off does not work intermittently.Customer stated that it cause a blood clot".Questionnaire not received from customer or clinician.Device not received manufacturer at this time.
Additional Manufacturer Narrative
H3, h6: one cryo/cuff ic cooler (item number 51a, serial number (b)(6) was returned for evaluation.Product was evaluated and all components were found to be in good condition.Functional test was performed and the motor worked correctly.Evaluation was unable to confirm the reported problem "motor will not turn off does not work intermittently" or anything that would cause blood clots in the patient.H11: corrected data: d2, g5, h8.

• Brand Name: AIRCAST
• Common Device Name: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 7419462
• Report Number: 9616086-2018-00008
• Device Sequence Number: 1637471
• Product Code: ILO
• UDI-Device Identifier: 00888912009102
• UDI-Public: 00888912009102
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K925677
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2020

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: Lay User/Patient
• Device Model Number: 51A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 01/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other