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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA INTELECT TRANSPORT COMBO PKG US STD; STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
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DJO, LLC CHATTANOOGA INTELECT TRANSPORT COMBO PKG US STD; STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT Back to Search Results
Model Number 2738
Device Problems Electrical /Electronic Property Problem (1198); Sparking (2595)
Patient Problems No Consequences Or Impact To Patient (2199); Patient Problem/Medical Problem (2688)
Event Date 06/14/2019
Event Type  malfunction  
Manufacturer Narrative
No device was returned for evaluation.If the device is received, a follow-up report will be submitted upon completion of product evaluation.
 
Event Description
It was reported that the unit was "not always turning on or shutting off unexpectedly.The unit has a power surge and causing a spark at the electrode, no patient was injured." this reportedly occurred during treatment.No further information was provided.
 
Manufacturer Narrative
E2, e3: unknown.H3, h6: device was returned for evaluation.The product met specifications and did not malfunction per device evaluation.Unit and applicator passed functional testing.No leadwires or electrodes were sent in for evaluation.A new leadwire kit will be sent to the customer.
 
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Brand Name
CHATTANOOGA INTELECT TRANSPORT COMBO PKG US STD
Type of Device
STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
Manufacturer (Section D)
DJO, LLC
1430 decision street
vista CA 92081 9663
MDR Report Key8775280
MDR Text Key150584142
Report Number9616086-2019-00049
Device Sequence Number1
Product Code IMG
UDI-Device Identifier00888912021883
UDI-Public00888912021883
Combination Product (y/n)N
PMA/PMN Number
K040285
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 07/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2738
Was Device Available for Evaluation? No
Date Manufacturer Received06/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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