MAUDE Adverse Event Report: MAX-N; CABLE, TRANDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Device Problems Scratched Material (3020); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/18/2019

Event Type  malfunction  

Event Description

Exposed wires on neonatal o2 transducer lead.Occurred on 3 different transducers.All are recycled transducers.(b)(4).

• Brand Name: MAX-N
• Type of Device: CABLE, TRANDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
• MDR Report Key: 8363258
• MDR Text Key: 137243526
• Report Number: MW5084263
• Device Sequence Number: 3
• Product Code: DSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/20/2019
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 1 DA
• Patient Weight: 3