Nihon Kohden A1411-SA203PURecalls & reported problems
APK Technology Co.,Ltd. · Nihon Kohden Compatible Reusable SpO2 Sensor, Adult Soft Tip · Class 2
Data updated Oct 18, 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 06946725526453), received between Dec 8, 2023 and Dec 8, 2023 — classified as 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 8, 2023No Apparent Adverse Event; No Apparent Adverse Event
DESCRIBE EVENT : SPO2 READING LOW. IT WAS NOTED THAT THE SPO2 WAS READING LOWER THAN EXPECTED ON PTS. IT WAS RECHECKED WITH ANOTHER PULSE OXIMETER THAT GAVE A READING MORE IN LINE WITH THE PT'S PRESENTATION AND SHOWED A SIGNIFICANT DIFFERENCE. THE EXPECTED VARIANCE WAS GREATER THAN (B)(4). COMPLETED IN HOSPITAL COMPARING WITH ANOTHER TRUSTED DEVICE. INVESTIGATION SITUATION: 1. ON SEPTEMBER 15, 2023, OUR COMPANY RECEIVED AN EMAIL NOTIFICATION FROM THE FDA TO NOTIFY THE MDR REPORT, AND IMMEDIATELY ORGANIZED AN INVESTIGATION AFTER RECEIPT, AND FOUND THAT THE PRODUCT SERIAL NUMBER WAS NOT PROVIDED IN THE MDR REPORT, WHICH COULD NOT BE TRACED BACK TO THE FAILURE OF THE SPECIFIC BATCH OF PRODUCTS. OUR COMPANY IMMEDIATELY CONTACTED THE AGENCY WHO DID THE REPORT BY E-MAIL, AND AT THE SAME TIME CONTACTED THE DEALER WHO SOLD THE PRODUCT BY E-MAIL TO INQUIRE ABOUT THE RELEVANT SERIAL NUMBER INFORMATION AND USAGE; 2. I DID NOT RECEIVE ANY FEEDBACK 3 DAYS AFTER THE EMAIL WAS SENT, AND I SENT ANOTHER EMAIL TO FOLLOW UP ON (B)(6), 2023; 3. ON (B)(6), 2023, WE RECEIVED FEEDBACK FROM THE CUSTOMER (THE DISTRIBUTOR OF THE PRODUCT): THE SERIAL NUMBER INFORMATION OF THE PRODUCT COULD NOT BE PROVIDED, A
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18289188 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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