MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ONESTEP; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 8900-0214-01

Device Problems Electrical /Electronic Property Problem (1198); Material Separation (1562)

Patient Problems Airway Obstruction (1699); Ventricular Fibrillation (2130); Low Oxygen Saturation (2477)

Event Date 04/26/2023

Event Type  malfunction  

Event Description

Patient arrived post op after mdlb (microdirect laryngoscopy and bronchoscopy procedure) and debulking of subglottic mass.Upon arrival patient came extubated but still sedated.Patient with desaturations- rn suctioned "two clots" patient continued to drop saturations - staff assist called.Airway management (ent also at bedside) and stabilization techniques occurred which included two doses of (partial dose concentration) narcan.Patient seemed to stabilize but then began to have arrhythmias including what appeared to be v-fib (ventricular fibrillation).Code called: backboard placed, compressions initiated- after a short period of compressions patient responding with movement.Patient given lidocaine, intubated with plan for echocardiogram scan and eeg procedure.Areas for improvement identified in debrief: 1) one-step defibrillator pads (when disconnected) part of the face of the connection port came off exposing wires.(new defib pads placed on patient) the defibrillator pads were disconnected to move the patient and part of the face of the connection port ripped off and exposed the wires.The pads were fully removed.2) pharmacy outside room given/utilized an incorrect code sheet.Meds that were drawn up inside the room by nursing staff utilizing the correct code sheet.3) difficulties with room space due to lots of equipment needed and patient in negative pressure n95 room.No harm detected to patient.Pads involved in this event were disposed.

• Brand Name: ONESTEP
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 16960809
• MDR Text Key: 315548076
• Report Number: 16960809
• 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: 05/05/2023

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: 8900-0214-01
• Device Catalogue Number: 8900-0214-01
• Device Lot Number: 1122B
• 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: 05/05/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/19/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/19/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 5475 DA
• Patient Sex: Male