MAUDE Adverse Event Report: ANGIODYNAMICS IVY ECG LEAD WIRES; ECG LEAD WIRES, METALLIC, 4 LEAD SET, IEC, 36 IN

Catalog Number 590445

Device Problem Failure to Read Input Signal (1581)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2022

Event Type  malfunction  

Event Description

1st of 2 malfunctioning devices: an angiodynamics regional business manager reported an issue with the 36" lead wires and 4 lead, low noise patient cable.It was reported that they "defaulted" during a procedure.Due to this issue, the procedure was aborted and rescheduled.The patient was under general anesthesia at the time but did not experience any adverse effects or harm as a result of this incident.This event meets the criteria a reportable adverse event; patient safety risk as treatment was not provided, but patient had been sedated.

Manufacturer Narrative

The ivy ecg lead wires have yet to be returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.The results of the investigation will be sent via a follow up medwatch.(b)(4) 1st malfunctioning device: reference (b)(4), medwatch 1319211-2022-00052 2nd malfunctioning device: reference (b)(4), medwatch 1319211-2022-00053.

Manufacturer Narrative

As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The reported complaint description could not be confirmed as no sample was returned.Without receiving the complaint sample for evaluation, a definitive root cause cannot be determined.A review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.  the review confirms that the lots met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.Labeling review: the user manual (ivy biomedical user manual, 3232-00-16), which is supplied to the user with this unit states "to monitor and display the patient's ecg waveform accurately (within limits of 60601-2-27).Warning: this unit uses a common isolation path for the ecg leads and electrodes.Do not allow the ecg leads and/or electrodes to come in contact with other conductive parts including earth ground.Do not connect any non-isolated accessories to the ecg input when connected to a patient, as this may compromise the safety of the unit.When attached to other devices, ensure that the total chassis leakage currents of all units do not exceed 300 [?]a.This equipment is protected against electrosurgery potentials.To avoid the potential of electrosurgery burns at monitoring sites, ensure proper connection of the electrosurgery return circuit as described by the manufacturer's instructions.If improperly connected, some electrosurgery units might allow energy to return through the ecg electrodes.This equipment returns to normal operation in less than 10 seconds.The model 7600/7800 is an easy-to-use cardiac trigger monitor that features a bright color touch screen lcd display.The model 7600/7800 displays two simultaneous ecg vectors and the patient's heart rate.The trigger ecg vector (top ecg waveform) can be selected from leads i, ii iii or auto.The second ecg vector (bottom ecg waveform) can be selected from leads i, ii or iii.In addition, high and low heart rate alarm limits can be adjusted to bracket the patient's heart rate so that a violation of these limits produces an audible and visual indication of the violation.The model 7600/7800 color display includes dual ecg traces, large heart rate numbers and alphanumeric characters for other data, alarm messages, menus and user information.Caution: ecg patient connections are electrically isolated type cf for ecg connections use insulated probes.Don't let patient connections contact other conductive parts, including earth.See instructions for patient connections in this manual.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference: (b)(4).1st malfunctioning device: reference (b)(4), medwatch 1319211-2022-00052, 2nd malfunctioning device: reference (b)(4), medwatch 1319211-2022-00053.

• Brand Name: IVY ECG LEAD WIRES
• Type of Device: ECG LEAD WIRES, METALLIC, 4 LEAD SET, IEC, 36 IN
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587805
• MDR Report Key: 15788393
• MDR Text Key: 307911909
• Report Number: 1319211-2022-00052
• Device Sequence Number: 1
• Product Code: DSA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K942321
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2023

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: Health Professional
• Device Catalogue Number: 590445
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2022
• Initial Date FDA Received: 11/14/2022
• Supplement Dates Manufacturer Received: 02/13/2023
• Supplement Dates FDA Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male