Internal Handle 1011-0139-01Recalls & reported problems
Zoll Medical Corporation · Class 2
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00847946022327), received between Aug 3, 2020 and Jun 13, 2022 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Failure to Deliver Shock/Stimulation” (4 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Failure to Deliver Shock/Stimulation4
- Failure of Device to Self-Test2
- Unable to Obtain Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient2
- No Information2
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 13, 2022Failure of Device to Self-Test; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE ASSOCIATED DEVICE FAILED SELF TEST USING THESE INTERNAL 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 14678204 ↗MalfunctionJun 13, 2022Failure of Device to Self-Test; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE ASSOCIATED DEVICE FAILED SELF TEST USING THESE INTERNAL 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 14678063 ↗MalfunctionMar 23, 2022Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN), THE ASSOCIATED DEVICE FAILED TO DISCHARGE USING THESE INTERNAL HANDLES. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13871077 ↗MalfunctionDec 21, 2020Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN), THE ASSOCIATED DEVICE FAILED TO DISCHARGE USING THESE INTERNAL PADDLES. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER SET OF INTERNAL PADDLES TO CONTINUE TREATING THE PATIENT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Information
MAUDE report 11048115 ↗MalfunctionDec 21, 2020Unable to Obtain Readings; Unable to Obtain Readings
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN), THE ASSOCIATED DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA (B)(6). COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER SET OF PADDLES TO CONTINUE TREATING THE PATIENT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Information
MAUDE report 11048043 ↗MalfunctionOct 26, 2020Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE ASSOCIATED DEFIBRILLATOR FAILED TO DISCHARGE USING THESE INTERNAL HANDLES. 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 10736397 ↗MalfunctionAug 3, 2020Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN), THE ASSOCIATED DEVICE FAILED TO DISCHARGE USING THESE ATTACHED INTERNAL HANDLES. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT AND REVERTED TO PHARMACOLOGY TO CONVERT 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 10356232 ↗
Other Dc-defibrillator, low-energy, (including paddles) devices
- NA 11131Physio-Control, Inc. · Dc-defibrillator, low-energy, (including paddles)1 recall6 reports
- NA 11131Physio-Control, Inc. · Dc-defibrillator, low-energy, (including paddles)1 recall5 reports
- NA 11131Physio-Control, Inc. · Dc-defibrillator, low-energy, (including paddles)1 recall1 report
- NA 11131Physio-Control, Inc. · Dc-defibrillator, low-energy, (including paddles)1 recall0 reports
- NA 11131Physio-Control, Inc. · Dc-defibrillator, low-energy, (including paddles)1 recall0 reports
- NA 11131Physio-Control, Inc. · Dc-defibrillator, low-energy, (including paddles)1 recall0 reports
- NA 11131Physio-Control, Inc. · Dc-defibrillator, low-energy, (including paddles)1 recall0 reports
- NA 11131Physio-Control, Inc. · Dc-defibrillator, low-energy, (including paddles)1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.