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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DJO, LLC AIRCAST; PACK, HOT OR COLD, WATER CIRCULATING
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DJO, LLC AIRCAST; PACK, HOT OR COLD, WATER CIRCULATING Back to Search Results
Model Number 51A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Thrombosis (2100)
Event Date 03/24/2018
Event Type  Injury  
Event 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.
 
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.
 
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Brand Name
AIRCAST
Type of Device
PACK, HOT OR COLD, WATER CIRCULATING
Manufacturer (Section D)
DJO, LLC
1430 decision street
vista CA 92081 9663
MDR Report Key7419462
MDR Text Key105105990
Report Number9616086-2018-00008
Device Sequence Number1
Product Code ILO
UDI-Device Identifier00888912009102
UDI-Public00888912009102
Combination Product (y/n)N
PMA/PMN Number
K925677
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 01/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number51A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/18/2020
Was the Report Sent to FDA? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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