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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE HEALTHCARE FINLAND OY N/A; CABLE, ELECTRODE

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GE HEALTHCARE FINLAND OY N/A; CABLE, ELECTRODE Back to Search Results
Model Number ECG Leadwire set, 5-lead, grouped, grabber, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/31/2019
Event Type  malfunction  
Event Description
Apm notified by pacu staff rn the ge ecg leads had a slit in the coating, exposing wire.Leads were not in use and removed from monitor and service immediately.Available to risk upon request.
 
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Brand Name
N/A
Type of Device
CABLE, ELECTRODE
Manufacturer (Section D)
GE HEALTHCARE FINLAND OY
3000 n. grandview blvd.
waukesha WI 53188
MDR Report Key8920330
MDR Text Key155191470
Report Number8920330
Device Sequence Number1
Product Code IKD
UDI-Device Identifier00840682139786
UDI-Public(01)00840682139786
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 07/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberECG Leadwire set, 5-lead, grouped, grabber, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in
Device Catalogue Number2106389-005
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/31/2019
Event Location Hospital
Date Report to Manufacturer08/22/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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