MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ONESTEP PEDIATRIC CPR MULTI-FUNCTION ELECTRODE; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	8900-000219-01
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Infant patient came into the emergency department being given cpr by ems crew.Patient moved to resuscitation room.Staff opened package of onestep cpr zoll monitor pads, and when posterior pad was pulled from sheet, the pad separated.It separated between the bottom white foam pad and the blue foam layer.They completely separated.Staff placed the layers back together and placed on patient but could not get reading/rhythm.They opened another onestep monitor pads package, and the same thing happened, again only to the posterior pad.By this time, they had put other monitor electrodes on patient, and could see that he was not in a shockable rhythm.The failure of the zoll onestep pads could have been detrimental to the patient because if he was in a shockable rhythm, they would have wanted to use that monitor to shock him, which those pads have the ability to do when working correctly.In this case though, he was not in a shockable rhythm; so the failure of the zoll monitor pads did not cause any harm/injury.Staff had the actual zoll monitor checked three different times that day, and all three techs said the monitor was working correctly, so our conclusion is the pads were what caused the issue.

• Brand Name: ONESTEP PEDIATRIC CPR MULTI-FUNCTION ELECTRODE
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 19917101
• Report Number: 19917101
• Device Sequence Number: 12574004
• Product Code: MKJ
• UDI-Device Identifier: 00847946023348
• UDI-Public: (01)00847946023348(17)251014(10)4123A
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/05/2024
• Report Date (Section F): 06/05/2024

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
• Operator of Device: Health Professional
• Device Model Number: 8900-000219-01
• Device Catalogue Number: 8900-000219-01
• Device Lot Number: 4123A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/06/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/06/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 2 MO
• Patient Sex: Male
• Patient Weight: 7 KG
• Date Report Sent to FDA: 06/05/2024