M SERIES BIPHASICRecalls & reported problems across all models
Zoll Medical Corporation · 59 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 572
- Deaths reported
- 5
- Injuries reported
- 1
- Recalls
- 0
We found 59 models of M SERIES BIPHASIC by Zoll Medical Corporation in the FDA's device registry (GUDID). Together they are named in 572 adverse event reports in the FDA's MAUDE database, received between Jun 8, 2015 and Jan 13, 2022 — classified as 5 deaths, 1 injury, 564 malfunctions.
The most frequently reported specific device problem is “Failure to Power Up” (143 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported M SERIES BIPHASIC problems
Device problems
- Failure to Power Up143
- Device Displays Incorrect Message72
- Defibrillation/Stimulation Problem52
- Failure of Device to Self-Test45
- No Display/Image40
- Pacing Problem35
- Failure to Charge27
- Failure to Discharge26
Patient problems
- No Patient Involvement508
- No Information34
- No Consequences Or Impact To Patient17
- Death5
- No Clinical Signs, Symptoms or Conditions3
- No Known Impact Or Consequence To Patient3
- Cardiac Arrest1
- Vitrectomy1
M SERIES BIPHASIC models
59 models, most reported first. Each model has its own page with its reports, recalls and device details.
- M SERIES BIPHASIC 40010011100123010PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)1 death247 reports
- M SERIES BIPHASIC 40010511100123010PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)77 reports
- M SERIES BIPHASIC 40010011100103011PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)48 reports
- M SERIES BIPHASIC 40010711100123010PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)14 reports
- M SERIES BIPHASIC 40010311100123010Automated external defibrillators (non-wearable)13 reports
- M SERIES BIPHASIC 60010211100123010Automated external defibrillators (non-wearable)1 death13 reports
- M SERIES BIPHASIC 60021711100163010ELECTROCARDIOGRAPH13 reports
- M SERIES BIPHASIC 60021711100123010Automated external defibrillators (non-wearable)1 death10 reports
- M SERIES BIPHASIC 40010011100163011Automated external defibrillators (non-wearable)1 death9 reports
- M SERIES BIPHASIC 60010011100123010PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)9 reports
- M SERIES BIPHASIC 40010011100163010PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)8 reports
- M SERIES BIPHASIC 40010511100124010ELECTROCARDIOGRAPH8 reports
- M SERIES BIPHASIC 40010511101123010ELECTROCARDIOGRAPH7 reports
- M SERIES BIPHASIC 40021711110123010Automated external defibrillators (non-wearable)7 reports
- M SERIES BIPHASIC 40010511100103010PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)6 reports
- M SERIES BIPHASIC 40021711100123010PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAPERITONEAL6 reports
- M SERIES BIPHASIC 60010011100103011PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)6 reports
- M SERIES BIPHASIC 60010011100103010ELECTROCARDIOGRAPH5 reports
- M SERIES BIPHASIC 40021511100123010Automated external defibrillators (non-wearable)4 reports
- M SERIES BIPHASIC 60010211100103010Automated external defibrillators (non-wearable)4 reports
- M SERIES BIPHASIC 60021311100123010PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)4 reports
- M SERIES BIPHASIC 40021311110123010ELECTROCARDIOGRAPH3 reports
- M SERIES BIPHASIC 40021711100124010Automated external defibrillators (non-wearable)3 reports
- M SERIES BIPHASIC 60010511100123010ELECTROCARDIOGRAPH3 reports
- M SERIES BIPHASIC 60010011100163010Automated external defibrillators (non-wearable)3 reports
- M SERIES BIPHASIC 40010711100103010PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAPERITONEAL2 reports
- M SERIES BIPHASIC 40021011100123010PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)2 reports
- M SERIES BIPHASIC 40021711100163010PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)2 reports
- M SERIES BIPHASIC 60010211100163010ELECTROCARDIOGRAPH2 reports
- M SERIES BIPHASIC 60010211100124010Automated external defibrillators (non-wearable)2 reports
- M SERIES BIPHASIC 60010711100123010PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)2 reports
- M SERIES BIPHASIC 60021011100123010Automated external defibrillators (non-wearable)2 reports
- M SERIES BIPHASIC 60021011100163010PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAPERITONEAL1 death2 reports
- M SERIES BIPHASIC 40010011100023010PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)1 report
- M SERIES BIPHASIC 40010011100063010ELECTROCARDIOGRAPH1 report
- M SERIES BIPHASIC 40010010100010013ELECTROCARDIOGRAPH1 report
- M SERIES BIPHASIC 40010211100163011ELECTROCARDIOGRAPH1 report
- M SERIES BIPHASIC 40010211101123010ELECTROCARDIOGRAPH1 report
- M SERIES BIPHASIC 40010311100103010Automated external defibrillators (non-wearable)1 report
- M SERIES BIPHASIC 40010311101103010PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)1 report
- M SERIES BIPHASIC 40010511100023010PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAPERITONEAL1 report
- M SERIES BIPHASIC 40010511100163010ELECTROCARDIOGRAPH1 report
- M SERIES BIPHASIC 40010511101124010PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAPERITONEAL1 report
- M SERIES BIPHASIC 40010711100163010Automated external defibrillators (non-wearable)1 report
- M SERIES BIPHASIC 40021311100123010PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAPERITONEAL1 report
- M SERIES BIPHASIC 40021311100173010Automated external defibrillators (non-wearable)1 report
- M SERIES BIPHASIC 40021511100124010Automated external defibrillators (non-wearable)1 report
- M SERIES BIPHASIC 40021511110123010ELECTROCARDIOGRAPH1 report
- M SERIES BIPHASIC 40021761100123010PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)1 report
- M SERIES BIPHASIC 40021711110163010ELECTROCARDIOGRAPH1 report
- M SERIES BIPHASIC 60010311100163010PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)1 report
- M SERIES BIPHASIC 60010511100103010PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)1 report
- M SERIES BIPHASIC 60010011100010011ELECTROCARDIOGRAPH1 report
- M SERIES BIPHASIC 60010011100023010Automated external defibrillators (non-wearable)1 report
- M SERIES BIPHASIC 60010011100063010ELECTROCARDIOGRAPH1 report
- M SERIES BIPHASIC 60021711110123010Automated external defibrillators (non-wearable)1 report
- M SERIES BIPHASIC 60021211100103010Automated external defibrillators (non-wearable)1 report
- M SERIES BIPHASIC 60021511100103010PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)1 report
- M SERIES BIPHASIC 60021511100123010PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAPERITONEAL1 report
Recent M SERIES BIPHASIC adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJan 13, 2022Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED A "DEFIB FAULT 72" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13254324 ↗MalfunctionSep 1, 2021Unable to Obtain Readings; Unable to Obtain Readings
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A (B)(6) YEAR-OLD FEMALE PATIENT, THE DEVICE DISPLAYED A "POOR PAD CONTACT" MESSAGE VIA EXTERNAL PADDLES. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED A SET OF INTERNAL HANDLES TO CONTINUE TREATING THE PATIENT. 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 12410996 ↗MalfunctionAug 17, 2021No Display/Image; No Display/Image
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE POWERED ON WITHOUT DISPLAY. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12333273 ↗MalfunctionOct 15, 2020Failure to Charge; Failure to Charge
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE FAILED TO CHARGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Information
MAUDE report 10684443 ↗MalfunctionOct 14, 2020Failure of Device to Self-Test; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE FAILED SELF TEST. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 10678526 ↗MalfunctionOct 7, 2020Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED A "DEFIB FAULT 72" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 10644604 ↗MalfunctionSep 21, 2020Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE WOULD NOT POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 10560543 ↗MalfunctionSep 8, 2020Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED A "BRIDGE TEST FAILED" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 10502269 ↗MalfunctionAug 27, 2020Unexpected Shutdown; Unexpected Shutdown
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE INAPPROPRIATELY SHUT DOWN. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 10461302 ↗MalfunctionAug 19, 2020Failure of Device to Self-Test; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE FAILED SELF TEST. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 10425135 ↗DeathAug 17, 2020Failure to Select Signal; Failure to Select Signal
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE WAS UNABLE TO SELECT ENERGY LEVEL. COMPLAINANT INDICATED THAT THE DEVICE DELIVERED 100 JOULES; BUT WHEN INCREASING THE ENERGY LEVEL THE BUTTON DID NOT ACTUATE. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.
Patient problems: Death
MAUDE report 10417610 ↗MalfunctionAug 17, 2020Pacing Problem; Pacing Problem
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED A "PACER FAULT 117" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 10417052 ↗MalfunctionAug 4, 2020No Display/Image; Unable to Obtain Readings; No Display/Image; Unable to Obtain Readings
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE'S DISPLAY INTERMITTENTLY BLANKED OUT AND DISPLAYED AN "ECG FAULT" ERROR MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 10364466 ↗MalfunctionAug 4, 2020Mechanics Altered; Mechanics Altered
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE WAS UNABLE TO SWITCH MODES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 10362306 ↗MalfunctionJul 29, 2020Unable to Obtain Readings; Unable to Obtain Readings
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED A "POOR PAD CONTACT" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 10338431 ↗
Other Zoll Medical Corporation products
- R SERIES94 models · 8,522 reports
- X SERIES163 models · 6,915 reports
- AED PLUS30 models · 1,966 reports · 1 recall
- Z Vent6 models · 1,204 reports · 1 recall
- Model EMV+ Vent, Army, MRI3 models · 964 reports
- E SERIES160 models · 833 reports
- ONESTEP8 models · 586 reports
- Powerheart G5 Kit, Auto, US Eng/ESP LA2 models · 350 reports · 4 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page