RICHMAR AUTOSOUND 9.6 400-021

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-11-09 for RICHMAR AUTOSOUND 9.6 400-021 manufactured by Compass Richmar Llc.

Event Text Entries

[91557758] In summary, per the letter from the high school's athletic department - (b)(6) 2017, 7:30 am, the end-user, (b)(6), came into the athletic training room (at the high school) after running cross country morning workouts around the grass fields. It was fairly humid around 7:00 am when they began running. He sat on the table closest to the exit to receive treatment on a right achilles soreness he had been experiencing for the past few weeks. He had electrodes placed on his lateral and medical lower leg around his sore area. He was hooked up by 11th grade student trainer, (b)(6). He had been on for about a couple minutes when he loses consciousness. Assistant athletic trainer, (b)(6) was in the back getting ice for another athlete, when the student trainer began yelling for him. (b)(6) is slumped over. (b)(6) ran to (b)(6) immediately to check for a pulse, asking, "are you with me (b)(6)? " (b)(6) is taken off the e-stim unit immediately at this time. (b)(6) holds (b)(6) up so he doesn't fall off the table. (b)(6) is sitting and slumped towards the right - he wakes up and looks lethargic; his pupils are dilated. Another athlete, (b)(6), was hooked up to the same machine next to (b)(6). (b)(6) stated that he felt weak and sleepy. (b)(6) then passes out again, and begins seizing. (b)(6) calls 911 as (b)(6) assess (b)(6). (b)(6) is broken out in a cold sweat all over his body - he wakes up about 10-15 seconds later, and asks what happened. (b)(6) tells (b)(6) what's happened, and (b)(6) immediately begins remembering things. (b)(6) lays (b)(6) down and elevates his lower extremities. (b)(6) grabs his pulse oximeter and it shows he has about 96-97% oxygen with a pulse around 58-62 bpm. (b)(6) is alert and talking to (b)(6) again. (b)(6) gets off the phone with 911, and the mom is called - she is on her way. Ems then arrives and begins assessing. The dad then called (b)(6) to question the machine - (b)(6) tells him it is a tens unit that many of the athletes use daily to receive treatment - (b)(6) is alert now and ems is there.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012316249-2017-00130
MDR Report Key7016008
Report SourceCONSUMER
Date Received2017-11-09
Date of Report2017-11-09
Date of Event2017-09-21
Date Mfgr Received2017-10-12
Date Added to Maude2017-11-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. KAYCEE NICHOLS
Manufacturer Street6753 ENGLE ROAD
Manufacturer CityMIDDLEBURG HEIGHTS OH 44130
Manufacturer CountryUS
Manufacturer Postal44130
Manufacturer Phone4402682579
Manufacturer G1COMPASS RICHMAR LLC
Manufacturer Street4120 S CREEK RD
Manufacturer CityCHATANOOGA TN 37406
Manufacturer CountryUS
Manufacturer Postal Code37406
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRICHMAR AUTOSOUND 9.6
Generic NameULTRASOUND
Product CodeGZJ
Date Received2017-11-09
Model Number400-021
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCOMPASS RICHMAR LLC
Manufacturer Address4120 S CREEK RD CHATANOOGA TN 37406 US 37406


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2017-11-09

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