MAX-N

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-21 for MAX-N manufactured by .

Event Text Entries

[137243526] Exposed wires on neonatal o2 transducer lead. Occurred on 3 different transducers. All are recycled transducers. (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5084263
• MDR Report Key: 8363258
• Date Received: 2019-02-21
• Date of Report: 2019-02-20
• Date of Event: 2019-02-18
• Date Added to Maude: 2019-02-22
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: MAX-N
• Generic Name: CABLE, TRANDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
• Product Code: DSA
• Date Received: 2019-02-21
• Returned To Mfg: 2019-02-19
• Lot Number: 9141344
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0

Device Sequence Number: 2

• Brand Name: MAX-N
• Generic Name: CABLE, TRANDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
• Product Code: DSA
• Date Received: 2019-02-21
• Returned To Mfg: 2019-02-19
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0

Device Sequence Number: 3

• Brand Name: MAX-N
• Generic Name: CABLE, TRANDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
• Product Code: DSA
• Date Received: 2019-02-21
• Returned To Mfg: 2019-02-19
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-02-21