DIGITALDIAGNOST 3.1.X 712026

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-09 for DIGITALDIAGNOST 3.1.X 712026 manufactured by Philips Medical Systems Dmc Gmbh.

Event Text Entries

[141454358] (b)(4). The investigation is still ongoing on this event. When the investigation is completed a follow-up report will be sent to the fda.
Patient Sequence No: 1, Text Type: N, H10


[141454359] The foot plate of the patient support for stitching fell on the foot of the doctor. Operator received skin abrasion. Minor injury occurred.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003768251-2019-00005
MDR Report Key8496015
Date Received2019-04-09
Date of Report2019-03-12
Date Mfgr Received2019-03-12
Date Added to Maude2019-04-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. DUSTY LEPPERT
Manufacturer StreetROENTGENSTR. 24
Manufacturer CityHAMBURG 22335
Manufacturer CountryGM
Manufacturer Postal22335
Manufacturer Phone405078-229
Manufacturer G1PHILIPS MEDICAL SYSTEMS
Manufacturer Street3000 MINUTEMAN ROAD
Manufacturer CityANDOVER MA 01810
Manufacturer CountryUS
Manufacturer Postal Code01810
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameDIGITALDIAGNOST 3.1.X
Generic NameSOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
Product CodeMQB
Date Received2019-04-09
Model Number712026
Catalog Number712026
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerPHILIPS MEDICAL SYSTEMS DMC GMBH
Manufacturer AddressROENTGENSTR. 24 HAMBURG 22335 GM 22335


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-09

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