MAUDE Adverse Event Report: GE HEALTHCARE FINLAND OY ECG TRUNK CABLE, 3/5-LEAD, AHA, 3.6 M/12 FT.; CABLE, ELECTRODE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Limb Fracture (4518)

Event Date 02/28/2023

Event Type  Injury  

Manufacturer Narrative

Legal manufacturer: hcs helsinki - kuortaneenkatu 2 finland helsinki etela-suomen laani, fin-00510.A1-6: there was no patient involved.G4: the product is 510(k) exempt.H4: the information is not available at this time.Gehc's investigation is on-going at this time.A follow-up report will be submitted when the investigation is complete.

Event Description

It was reported that a gehc employee tripped over the ecg trunk cable and sustained a fracture to their elbow.There was no patient involved.

Manufacturer Narrative

Investigation findings: it was reported that a ge healthcare (gehc) employee tripped on the ecg trunk cable, fell and fractured their elbow.The employee's arm was placed in a sling, but did not require any other medical/surgical intervention.The affected cable was not returned to gehc for analysis.A picture of the cable was reviewed by gehc engineering.The investigation found that due to its length (12ft), there is an inherent potential of a trip hazard.However, there was no indication of a product defect, or design/process issues that may have led to the reported injury.The root cause was use error.Historical data analysis did not show any adverse trend related to this issue.The product instructions for use cautions the user to handle the cable in a manner that would not present a trip hazard.Investigation findings: it was reported that a ge healthcare (gehc) employee tripped on the ecg trunk cable, fell and fractured their elbow.The employee's arm was placed in a sling, but did not require any other medical/surgical intervention.The affected cable was not returned to gehc for analysis.A picture of the cable was reviewed by gehc engineering.The investigation found that due to its length (12ft), there is an inherent potential of a trip hazard.However, there was no indication of a product defect, or design/process issues that may have led to the reported injury.The root cause was use error.Historical data analysis did not show any adverse trend related to this issue.The product instructions for use cautions the user to handle the cable in a manner that would not present a trip hazard.

• Brand Name: ECG TRUNK CABLE, 3/5-LEAD, AHA, 3.6 M/12 FT.
• Type of Device: CABLE, ELECTRODE
• Manufacturer (Section D): GE HEALTHCARE FINLAND OY; kuortaneenkatu 2; helsinki FIN-0 0510; FI FIN-00510
• Manufacturer (Section G): GE HEALTHCARE FINLAND OY; kuortaneenkatu 2; helsinki FIN-0 0510; FI FIN-00510
• Manufacturer Contact: kristof soos ; 8200 w tower ave; milwaukee, WI 53223
• MDR Report Key: 16898710
• MDR Text Key: 314864152
• Report Number: 9610105-2023-00004
• Device Sequence Number: 1
• Product Code: IKD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/14/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention