MAUDE Adverse Event Report: ZOLL PRO-PADS; ADULT MULTIFUNCTIONAL PADS

Lot Number 0416

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Paramedics responded to cardiac arrest in the field.They applied zoll multi-function defib/pacer pads and the monitor (zoll x-series) failed to show cardiac rhythm while in the "pads" mode.Monitor was replaced with the same result.New pads were applied with same result.The monitors were checked by our biomed department.And functioned correctly.Ems supervisors determined the pads (with the same lot number) are faulty and have been removed from service.

• Brand Name: PRO-PADS
• Type of Device: ADULT MULTIFUNCTIONAL PADS
• Manufacturer (Section D): ZOLL; chelmsford ME 01824
• MDR Report Key: 5495528
• MDR Text Key: 40225826
• Report Number: MW5060849
• Device Sequence Number: 1
• Product Code: MLN
• 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: 03/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2017
• Device Lot Number: 0416
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR