Internal Handle 1003-0143-06Recalls & reported problems
Zoll Medical Corporation · Class 2
All models of Internal Handle (14)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847946022440), received between Jun 9, 2023 and Jun 9, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Deliver Shock/Stimulation” (2 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 16, 2026.
Most reported problems
Device problems
- Failure to Deliver Shock/Stimulation2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 9, 2023Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE ASSOCIATED DEFIBRILLATOR FAILED TO DISCHARGE USING THESE INTERNAL HANDLES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17100861 ↗MalfunctionJun 9, 2023Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE ASSOCIATED DEVICE FAILED TO DISCHARGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17100842 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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