AMX-4 PLUS MOBILE X-RAY SYSTEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-10 for AMX-4 PLUS MOBILE X-RAY SYSTEM manufactured by Ge Medical Systems.

Event Text Entries

[141480665] The digital portable machine was brought over to the ed room 1 for a portable chest x-ray. The machine would not take the xray (3 tries). The technologist had to go switch machines back in radiology in order to take the portable chest xray. This device was serviced by (b)(4). Problem description: install handswitch and cable. Work performed: installed replacement handswitch and cable. Tested unit for proper operation and obtained satisfactory results.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8499894
MDR Report Key8499894
Date Received2019-04-10
Date of Report2019-02-21
Date of Event2019-02-14
Report Date2019-02-21
Date Reported to FDA2019-02-21
Date Reported to Mfgr2019-04-10
Date Added to Maude2019-04-10
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAMX-4 PLUS MOBILE X-RAY SYSTEM
Generic NameSYSTEM, X-RAY, MOBILE
Product CodeIZL
Date Received2019-04-10
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerGE MEDICAL SYSTEMS
Manufacturer Address3000 N GRANDVIEW BLVD. WAUKESHA WI 53188 US 53188


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-10

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