MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ONESTEP COMPLETE, SINGLE, R SERIES, ELECTRODES; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 8900-0224-01

Device Problems Loss of or Failure to Bond (1068); Material Deformation (2976)

Patient Problem Diaphoresis (2452)

Event Date 08/16/2022

Event Type  malfunction  

Event Description

(b)(4).The gel on the front pad rolled up.No harm at this time to patient, but gel should not roll up on the pads- could cause a 'no contact' pad function during a code blue.Given back to mfg for evaluation.(b)(4).Shock was given immediately, but as soon as cpr was resumed the defibrillator pads did not stick to the patient.Patient was diaphoretic during event, but defibrillator pads would not stay in place and had we needed to shock again we would have had to change the pads, resulting in a delay of care.After code was completed, it was noted that the gel on the front defibrillator pad was rolled up, as we have seen in photos of previous events with these specific pads.Unfortunately defibrillator pads and packaging were disposed of before any information could be recorded.No device for evaluation.

• Brand Name: ONESTEP COMPLETE, SINGLE, R SERIES, ELECTRODES
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 15401193
• MDR Text Key: 299681123
• Report Number: 15401193
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/08/2022

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
• Device Operator: Health Professional
• Device Model Number: 8900-0224-01
• Device Catalogue Number: R2018-33 213307611
• Device Lot Number: R2018-33 213307611
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/08/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/12/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1