Paddle 1001-001150-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00847946023010), received between Mar 23, 2017 and Dec 21, 2022 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver Shock/Stimulation” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 21, 2022Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE ASSOCIATED DEVICE FAILED TO DISCHARGE USING THESE PADDLES. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: Insufficient Information

  MAUDE report 16023443 ↗
• MalfunctionDec 20, 2022Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE ASSOCIATED DEVICE FAILED TO DISCHARGE USING THESE PADDLES. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16017896 ↗
• MalfunctionFeb 2, 2022Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE FAILED TO DISCHARGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: Insufficient Information

  MAUDE report 13425967 ↗
• MalfunctionNov 29, 2021Failure to Charge; Failure to Charge

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE FAILED TO CHARGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12887795 ↗
• MalfunctionJun 30, 2020Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE FAILED TO DISCHARGE VIA EXTERNAL PADDLES (SN (B)(4). NO INFORMATION WAS AVAILABLE ON WHICH TYPE OF DEVICE WAS INVOLVED. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 10212691 ↗
• MalfunctionNov 26, 2019Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE FAILED TO DISCHARGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 9375567 ↗
• MalfunctionAug 5, 2019Failure to Convert Rhythm; Failure to Convert Rhythm

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A (B)(6) MALE PATIENT, DURING AORTIC VALVE REPLACEMENT SURGERY, THE DEVICE FAILED TO CARDIOVERT THE PATIENT'S RHYTHM USING EXTERNAL PADDLES. COMPLAINANT INDICATED THAT THE CLINICIAN ATTACHED ELECTRODE PADS TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8861582 ↗
• MalfunctionAug 20, 2018Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  COMPLAINANT ALLEGED THAT DURING INCOMING TESTING, THE DEVICE CAUSED THE ASSOCIATED DEFIBRILLATOR TO DISPLAY A "RELEASE BUTTON" MESSAGE USING THESE EXTERNAL PADDLES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 7797593 ↗
• MalfunctionApr 18, 2018Failure to Discharge; Failure to Discharge

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE FAILED TO DISCHARGE USING EXTERNAL PADDLES ((B)(4)). COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH REPORTS 1220908-2018-01060 AND 1220908-2018-01063 FOR SIMILAR EVENTS REPORTED FROM THE SAME CUSTOMER.

  Patient problems: No Patient Involvement

  MAUDE report 7440340 ↗
• MalfunctionApr 18, 2018Failure to Discharge; Failure to Discharge

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE FAILED TO DISCHARGE USING EXTERNAL PADDLES ((B)(4)). COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH REPORTS 1220908-2018-01060 AND 1220908-2018-01062 FOR SIMILAR EVENTS REPORTED FROM THE SAME CUSTOMER.

  Patient problems: No Patient Involvement

  MAUDE report 7440321 ↗
• MalfunctionApr 18, 2018Failure to Discharge; Failure to Discharge

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE FAILED TO DISCHARGE USING EXTERNAL PADDLES ((B)(4)). COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH REPORTS 1220908-2018-01062 AND 1220908-2018-01063 FOR SIMILAR EVENTS REPORTED FROM THE SAME CUSTOMER.

  Patient problems: No Patient Involvement

  MAUDE report 7440298 ↗
• MalfunctionFeb 21, 2018Device Operational Issue; Device Operational Issue

  COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WAS UNABLE TO SELECT ENERGY LEVEL. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 7286946 ↗
• MalfunctionMar 23, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED A "DEFIB PAD SHORT" MESSAGE WITH DEFIBRILLATOR EXTERNAL PADDLES ATTACHED. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 6430307 ↗
• MalfunctionMar 23, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED A "DEFIB PAD SHORT" MESSAGE WITH DEFIBRILLATOR EXTERNAL PADDLES ATTACHED. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 6430249 ↗