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Sapphire External Battery Pack 15079-111-0001Recalls & reported problems

Eitan Medical Ltd · 6 AA 1.5V Alkaline . Output 10Vdc · Class 2

Data updated Oct 18, 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 17290109150083), received between Dec 18, 2016 and Dec 27, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Charge” (1 report).

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

Device problems

  • Failure to Charge1
  • Overheating of Device1
  • Use of Device Problem1

Patient problems

  • No Consequences Or Impact To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 27, 2018Overheating of Device; Use of Device Problem; Overheating of Device; Use of Device Problem

    THE EVENT WAS REPORTED BY A CUSTOMER FROM THE USA: EXTERNAL BATTERY PACK OVERHEATING DUE TO POSSIBLE USER ERROR.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8198948 ↗
  • MalfunctionDec 18, 2016Failure to Charge; Failure to Charge

    THE EVENT WAS REPORTED BY A CUSTOMER FROM USA: "EXTERNAL BATTERY PACKS, NOT WORKING DRAINING THE INTERNAL BATTERY AND NOT USING THE EXTERNAL BATTERY ALSO CAUSING BATTERY ACID TO LEAK. TWO EXTERNAL CAUSING BATTERY ACID LEAK. NO PHYSICAL DAMAGE. NO KNOWN INCIDENCE OF MISHANDLING. THE LEAKING OCCURRED IN THE EXTERNAL BATTER PACK. THE BATTERY PK WAS SENT TO BIO MED DEPARTMENT AND WAS CLEANED UP FOR REUSE. THE BATTERY PACK STILL SEEMS TO ONLY WORK SOMETIMES. PATIENT INVOLVEMENT: YES, HUMAN HARM: NO, DELAY IN THERAPY: YES, MEDICAL INTERVENTION NEEDED: NO."

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6184436 ↗

Other Accessories, Pump, Infusion devices

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Sources and updates

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