NEONATAL PREWIRED ELECTRODE 0.9 INCH

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-02 for NEONATAL PREWIRED ELECTRODE 0.9 INCH manufactured by Cardinal Health.

Event Text Entries

[77002016] Monitoring neonatal electrode wire placed on neonate to monitor heart rate was found to be disconnected from circular electrode pad. Electrode on patient less than 2 hours. Electrode replaced with new electrode and the same thing occurred with 3 different electrodes in a neonate that was not moving excessively. Electrodes replaced x 4. Is the product compounded: no. Is the product over-the-counter: no.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5070200
• MDR Report Key: 6618394
• Date Received: 2017-06-02
• Date of Report: 2017-06-02
• Date of Event: 2017-05-25
• Date Added to Maude: 2017-06-07
• 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
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• 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: NEONATAL PREWIRED ELECTRODE 0.9 INCH
• Generic Name: NEONATAL PREWIRED ELECTRODE
• Product Code: IKD
• Date Received: 2017-06-02
• Returned To Mfg: 2017-06-02
• Lot Number: 161227
• Device Expiration Date: 2019-12-30
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CARDINAL HEALTH
• Manufacturer Address: DUBLIN OH 43017 US 43017

Device Sequence Number: 2

• Brand Name: NEONATAL PREWIRED ELECTRODE 0.9 INCH
• Generic Name: NEONATAL PREWIRED ELECTRODE
• Product Code: IKD
• Date Received: 2017-06-02
• Returned To Mfg: 2017-06-02
• Lot Number: 161227
• Device Expiration Date: 2019-12-30
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: CARDINAL HEALTH
• Manufacturer Address: DUBLIN OH 43017 US 43017

Device Sequence Number: 3

• Brand Name: NEONATAL PREWIRED ELECTRODE 0.9 INCH
• Generic Name: NEONATAL PREWIRED ELECTRODE
• Product Code: IKD
• Date Received: 2017-06-02
• Returned To Mfg: 2017-06-02
• Lot Number: 161227
• Device Expiration Date: 2019-12-30
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: CARDINAL HEALTH
• Manufacturer Address: DUBLIN OH 43017 US 43017

Device Sequence Number: 4

• Brand Name: NEONATAL PREWIRED ELECTRODE 0.9 INCH
• Generic Name: NEONATAL PREWIRED ELECTRODE
• Product Code: IKD
• Date Received: 2017-06-02
• Returned To Mfg: 2017-06-02
• Lot Number: 161227
• Device Expiration Date: 2019-12-30
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: I
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: CARDINAL HEALTH
• Manufacturer Address: DUBLIN OH 43017 US 43017

Patients

Patient Number	Treatment	Outcome	Date
1	0		2017-06-02