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

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.

• 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 Key: 8920330
• MDR Text Key: 155191470
• Report Number: 8920330
• Device Sequence Number: 1
• Product Code: IKD
• UDI-Device Identifier: 00840682139786
• UDI-Public: (01)00840682139786
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ECG Leadwire set, 5-lead, grouped, grabber, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in
• Device Catalogue Number: 2106389-005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/31/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1