HeartStartRecalls & reported problems across all models

We found 3 models of HeartStart by Philips Medical Systems Hsg in the FDA's device registry (GUDID). Together they are named in 14 adverse event reports in the FDA's MAUDE database, received between Oct 14, 2019 and Nov 17, 2023 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (12 reports).

1 FDA recall record name at least one of these models by its device identifier.

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

HeartStart recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Nov 23, 2018Class IITerminated

   Affected lithium-ion batteries may contain a defective component (Thermal Cut-off or TCO). Should the component fail, the battery will no longer charge or deliver power to the Monitor/Defibrillator, which may prevent operation of the device if it is not connected to AC or DC power. Should a second, unaffected battery be present in the Monitor/Defibrillator, the battery failure may go unnoticed.

   Z-0603-2019 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported HeartStart problems

HeartStart models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• HeartStart MRx Lithium Ion Battery Module

  Automated external defibrillators (non-wearable)
  1 recall12 reports
• HeartStart Medium Switchless Int Pdl

  Dc-Defibrillator, Low-Energy, (Including Paddles)
  1 report
• HeartStart 3-Wire Lead Set and Plug Snap IEC

  PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
  1 report

Recent HeartStart adverse event reports

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

• InjuryNov 17, 2023Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  IT WAS REPORTED THAT DURING A VENTRICULAR RHYTHM PROBLEM OF THE PATIENT AT THE END OF THE INTERVENTION, THEY NEEDED TO USE THE DEFIBRILLATION PADDLES. AT THE MOMENT OF THE SHOCK, THE DEFIBRILLATOR TURNED OFF AND THE SHOCK WAS NOT ADMINISTERED. THE PADDLES SEEM TO HAVE CREATED AN ELECTRICAL SHORT-CIRCUIT.

  Patient problems: Unspecified Heart Problem; Ventricular Fibrillation

  MAUDE report 18158924 ↗
• MalfunctionOct 4, 2021Battery Problem; Battery Problem

  IT WAS REPORTED TO PHILIPS THAT THE BATTERY FAILS TO CHARGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12569038 ↗
• MalfunctionOct 4, 2021Battery Problem; Battery Problem

  IT WAS REPORTED TO PHILIPS THAT THE BATTERY FAILS TO CHARGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12568805 ↗
• MalfunctionAug 31, 2021Battery Problem; Battery Problem

  IT WAS REPORTED TO PHILIPS THAT THE BATTERY MALFUNCTIONED. THE CUSTOMER WORKED WITH THE TECHNICAL SUPPORT REPRESENTATIVE. THE CUSTOMER CONFIRMED THE NEED FOR A BATTERY EXCHANGE. THE REPORTED PROBLEM WAS VERIFIED IN THE LAB. THE BATTERY PACK WAS UNABLE TO CHARGE EITHER IN HEARTSTART MRX DEVICE OR A CADEX CHARGER. TROUBLESHOOTING CONDUCTED REVEALED FUSE F1 OPEN. THE FUSE WAS REPLACED AND THE BATTERY OPERATED AS NORMAL. THE CUSTOMER WAS SENT A BATTERY REPLACEMENT. THE BATTERY IS CUSTOMER REPLACEABLE. NO FURTHER ACTION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12390417 ↗
• MalfunctionJul 8, 2021Battery Problem; Failure of Device to Self-Test; Battery Problem; Failure of Device to Self-Test

  IT WAS REPORTED TO PHILIPS THAT THE RFU INDICATOR DISPLAYED A RED X AND THE ALARM SOUNDED. THERE WAS NO REPORTED PATIENT INVOLVEMENT,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12138031 ↗
• MalfunctionJun 28, 2021Battery Problem; Battery Problem

  IT WAS REPORTED TO PHILIPS THAT THE BATTERY FAILS TO CALIBRATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12081660 ↗
• MalfunctionJun 28, 2021Battery Problem; Battery Problem

  IT WAS REPORTED TO PHILIPS THAT THE BATTERY FAILS TO CALIBRATE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12080975 ↗
• MalfunctionJun 16, 2021Battery Problem; Battery Problem

  IT WAS REPORTED TO PHILIPS THAT THE BATTERY FAILS TO CHARGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12010519 ↗
• MalfunctionJun 16, 2021Battery Problem; Battery Problem

  IT WAS REPORTED TO PHILIPS THAT THE BATTERY FAILS TO CHARGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12006274 ↗
• MalfunctionJun 16, 2021Failure to Charge; Battery Problem; Failure to Charge; Battery Problem

  IT WAS REPORTED TO PHILIPS THAT THE BATTERY FAILS TO CHARGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12006270 ↗
• MalfunctionMay 22, 2021Battery Problem; Battery Problem

  IT WAS REPORTED TO PHILIPS THAT THE DEVICE BATTERY IS NOT RECOGNIZED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11868434 ↗
• MalfunctionMay 21, 2021Battery Problem; Battery Problem

  IT WAS REPORTED TO PHILIPS THAT THE BATTERY FAILS CALIBRATION BY ONLY BEING ABLE TO CHARGE TO 53%. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11864499 ↗
• MalfunctionNov 5, 2020Electrical /Electronic Property Problem; Loose or Intermittent Connection

  IT WAS REPORTED TO PHILIPS THAT THE ECG CABLE AND LEAD TEND TO COME LOOSE DURING USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10792654 ↗
• MalfunctionOct 14, 2019Battery Problem

  IT WAS REPORTED TO PHILIPS THAT THE BATTERY IS DEFECTIVE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9186578 ↗

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