alpHaONE JSPC-1Recalls & reported problems
Chongqing Jinshan Science & Technology (Group) Co., Ltd · pH capsule, 1 pack · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 06946332800045), received between Apr 3, 2025 and Apr 3, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Positioning Failure” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Positioning Failure1
Patient problems
- Aspiration/Inhalation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 3, 2025Positioning Failure; Positioning Failure
IT IS REPORTED THAT UPON PLACING THE PH CAPSULE, THE PROBE DISLODGED IN THE POSTERIOR OROPHARYNX REGION AND WAS SITTING ON THE VOCAL CORDS. AS THE MD ATTEMPTED TO GRAB THE PROBE WITH BIOPSY FORCEPS, THE PROBE ADVANCED INTO THE TRACHEA. PATIENT WAS STABILIZED AND INTUBATED. EMS CALLED IMMEDIATELY, ED NOTIFIED. PH CAPSULE WAS REMOVED BY SGR HOSPITAL. PT WAS THEN DISCHARGED FROM THE HOSPITAL.
Patient problems: Aspiration/Inhalation
MAUDE report 21759613 ↗
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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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