ZERO GRAVITY ZGM-6-5H

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-29 for ZERO GRAVITY ZGM-6-5H manufactured by Tidi Products, Llc.

Event Text Entries

[54211531]
Patient Sequence No: 1, Text Type: N, H10


[54211532] No patient involved. Incident involved a doctor using a zero-gravity overhead suspended radiation shielding system. The mechanical suspension means of the radiation shielding element ceased to hold up that component (root cause to be determined), resulting in it falling. The clamp block glanced off the doctor as it fell. The doctor reported that after the failure, he donned conventional lead shielding garb, completed the about-to-begin cardiac interventional procedure and the next-scheduled one, then went down to the er to have the clamp-block-impact site looked at. The doctor reported that he did not sustain a significant injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1825560-2016-00001
MDR Report Key5910395
Date Received2016-08-29
Date of Report2016-08-05
Date of Event2016-07-28
Date Mfgr Received2016-07-28
Device Manufacturer Date2014-11-13
Date Added to Maude2016-08-29
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 ContactMR. JOHN SCHAEFER
Manufacturer Street14241 FENTON ROAD
Manufacturer CityFENTON MI 48430
Manufacturer CountryUS
Manufacturer Postal48430
Manufacturer Phone8107505300
Manufacturer G1TIDI PRODUCTS, LLC
Manufacturer Street14241 FENTON ROAD
Manufacturer CityFENTON MI 48430
Manufacturer CountryUS
Manufacturer Postal Code48430
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameZERO GRAVITY
Generic NameRADIATION PROTECTION SYSTEM
Product CodeEAJ
Date Received2016-08-29
Returned To Mfg2016-08-04
Model NumberZGM-6-5H
OperatorPHYSICIAN
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTIDI PRODUCTS, LLC
Manufacturer Address14241 FENTON ROAD FENTON MI 48430 US 48430


Patients

Patient NumberTreatmentOutcomeDate
10 2016-08-29

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