MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION INTERNAL HANDLE; DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/02/2022

Event Type  malfunction  

Event Description

Patient was in a shockable rhythm and physician asked for paddles to be charged to 15 j.First defibrillation worked immediately.Patient still in shockable rhythm, second time zoll was charged, paddles would not deliver shock right away, when surgeon pushed button, shock not delivered though the rhythm was displaying on zoll display.Approx 20 seconds later and after two more tries, second shock delivered.While circulator opened new defibrillation cord and paddles, third attempt was made to shock and button did not respond when pushed by surgeon (again, rhythm was displayed on zoll).Zoll biomed number: redacted.Paddles ref: 00847946022235.Paddle 1: redacted.Paddle 2: redacted.Defibrillation cord: 00847946022433.Redacted numbers.Further review revealed: first shock 11:37:14 a 15j shock was present.The following successful shocks were also present: 11:37:25 a 15j shock, 11:37:53 a 15j shock, 11:38:08 a 15j shock, 11:41:03 a 20j shock, 11:41:19 a 20j shock, 11:41:34 a 20j shock, 11:42:54 a 20j shock.Additionally, there was three successful test shocks performed at 06:00:11, 09:38:31 and 12:09:02 each for 30j.Clinical engineering confirmed issue is not the defibrillator but the actual paddles.No harm came to the patient due to this event.Patient history-she was inpatient with hcm in the setting of rasopathy who presented for elective septal myectomy.Operative course complicated by peri-op vf with successful cardioversion as well as multiple bouts of svt with intermittent aberrancy.She was restarted on her metoprolol-xl and escalated to home dosing related to these episodes.Diuresis post-operatively initiated but developed significant negative fluid balance and in the setting of an on-going mid-cavitary obstruction it was weaned and then discontinued without clinical effect.Aicd was placed successfully with recurrent tachyarrhythmias thereafter prompting transition from toprol to sotalol.She remained stable and was discharged.

Event Description

Patient was in a shockable rhythm and physician asked for paddles to be charged to 15 j.First defibrillation worked immediately.Patient still in shockable rhythm, second time zoll was charged, paddles would not deliver shock right away, when surgeon pushed button, shock not delivered though the rhythm was displaying on zoll display.Approx 20 seconds later and after two more tries, second shock delivered.While circulator opened new defibrillation cord and paddles, third attempt was made to shock and button did not respond when pushed by surgeon (again, rhythm was displayed on zoll).Zoll biomed number: redacted.Paddles ref: (b)(4).Paddle 1: redacted.Paddle 2: redacted.Defibrillation cord: 00847946022433 redacted numbers further review revealed: first shock 11:37:14 a 15j shock was present.The following successful shocks were also present: 11:37:25 a 15j shock, 11:37:53 a 15j shock, 11:38:08 a 15j shock, 11:41:03 a 20j shock, 11:41:19 a 20j shock, 11:41:34 a 20j shock, 11:42:54 a 20j shock.Additionally, there was three successful test shocks performed at 06:00:11, 09:38:31 and 12:09:02 each for 30j.Clinical engineering confirmed issue is not the defibrillator but the actual paddles.No harm came to the patient due to this event.Patient history-she was inpatient with hcm in the setting of rasopathy who presented for elective septal myectomy.Operative course complicated by peri-op vf with successful cardioversion as well as multiple bouts of svt with intermittent aberrancy.She was restarted on her metoprolol-xl and escalated to home dosing related to these episodes.Diuresis post-operatively initiated but developed significant negative fluid balance and in the setting of an on-going mid-cavitary obstruction it was weaned and then discontinued without clinical effect.Aicd was placed successfully with recurrent tachyarrhythmias thereafter prompting transition from toprol to sotalol.She remained stable and was discharged.

• Brand Name: INTERNAL HANDLE
• Type of Device: DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 525 narragansett park dr; pawtucket RI
• MDR Report Key: 15073585
• MDR Text Key: 296304707
• Report Number: 15073585
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/15/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 6205 DA
• Patient Sex: Female
• Patient Weight: 73 KG