MAC 5500 HD 018344

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-20 for MAC 5500 HD 018344 manufactured by Ge Medical Systems Information Technologies, Inc.

Event Text Entries

[117572530] Patient seen in emergency room with complaints of shortness of breath, diaphoresis, chest pain, and headache. The nurse was attempting to get an ecg, but the mac 5500 hd gave an error message "limb lead disconnected". The nurse replaced the leads and attempted to get an ecg again, but the mac 5500 hd kept giving the same error message. The mac 5500 hd was replaced with another system, and the nurse was able to get an ecg. No untoward patient effects.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number7796619
MDR Report Key7796619
Date Received2018-08-20
Date of Report2018-07-17
Date of Event2018-07-15
Report Date2018-07-23
Date Reported to FDA2018-07-23
Date Reported to Mfgr2018-08-20
Date Added to Maude2018-08-20
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMAC 5500 HD
Generic NameELECTROCARDIOGRAPH
Product CodeDPS
Date Received2018-08-20
Model Number5500 HD
Catalog Number018344
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC
Manufacturer Address9900 INNOVATION DRIVE WAUWATOSA WI 53226 US 53226


Patients

Patient NumberTreatmentOutcomeDate
10 2018-08-20

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