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
- Medfusion 4000-0106-01Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION2 recalls4,390 reports
- Medfusion 4000-0105-51Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION2 recalls2,882 reports
- CADD 21-2111-0401-51Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION4 recalls461 reports
- CADD 21-2112-0402-78Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION3 recalls0 reports
- MEDFUSION 4000-0106-00Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION2 recalls10 reports
- Medfusion 3500-0600-00Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION2 recalls9 reports
- Medfusion 3500-0600-51Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION2 recalls2 reports
- Medfusion 4000-0105-78Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION2 recalls0 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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