Nasal Alar Sp02 Sensor 301-11214Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI B213301112140), received between Apr 14, 2019 and Jul 9, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2019Missing Information; Missing Information

  UPON ARRIVAL TO THE OPERATION ROOM, ANESTHESIA REMOVED PULSE OXIMETER CLIP FROM RIGHT SIDE OF THE NOSE. PRESSURE ULCER NOTED UNDER THE PULSE OXIMETER CLIP WAS A DARK REDDENED AREA SURROUNDED BY BLACK SKIN. ANESTHESIA CLEANED SKIN UNDER THE CLIP, AND APPLIED A NEW PULSE OXIMETER TO THE FINGER. PROGRESS NOTE READS: PRESSURE ULCER NOTED UNDER PULSE OXIMETER ON RIGHT SIDE OF NOSE. SKIN APPEARS BLACK WITH A REDDENED AREA. OTHER NOTES: PATIENT VITAL SIGNS: BP NORMAL TENSIVE (DIASTOLIC 120-150MMHG); RR TACHYCARDIC; TEMP 99.1 - 100.6 F. PATIENT ON VENTILATOR; BEDREST/BEDBOUND ON SKIN PRECAUTIONS (BRADEN SCORE FOR PRESSURE ULCERS SCORED PATIENT HIGH RISK.) THERE IS NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT WILL BE UPDATED IF RELEVANT BECOMES AVAILABLE.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 8772515 ↗
• InjuryApr 14, 2019Use of Device Problem; Use of Device Problem

  DURING IN-SERVICE TRAINING FOR THE PROPER PLACEMENT, SECUREMENT, AND THE NEED TO CHECK AND ROTATE THE SENSOR; A MEMBER OF THE NURSING STAFF REALIZED THAT A SENSOR ON A PATIENT HAD NOT BEEN CHECKED. THE PATIENT WAS EVALUATED AND SKIN UNDER THE SENSOR HAD BECOME VISIBLY PURPLE IN COLOR. THE NURSE SUGGESTED HER BEST GUESS WAS THAT THE SENSOR HAD BEEN IN PLACE FOR SEVERAL DAYS. THE PATIENT WAS RE-EVALUATED LATER IN THE EVENING AND THE SITE HAD TURNED NOTICEABLY DARKER WITH SOME THICKENING OF THE SURFACE. THE RISK MANAGEMENT DEPARTMENT FOR THE HOSPITAL WAS LATER CONTACTED TO OBTAIN ADDITIONAL INFORMATION. THEY WERE UNABLE TO LOCATE ANY REPORTS REGARDING THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE FROM THE HEALTHCARE FACILITY AT THIS TIME. THIS REPORT WILL BE UPDATED IF RELEVANT INFORMATION BECOMES AVAILABLE.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 8512561 ↗
• InjuryApr 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  WOUND CARE COORDINATOR IDENTIFIED PRESSURE INJURIES ON BOTH ALA OF A PATIENT. THE LEFT SIDE WAS A STAGE 4 WITH OBSERVED PRESSURE INJURY INSIDE AND OUTSIDE THE NOSTRIL. THE RIGHT SIDE WAS A STAGE 3. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT WILL BE UPDATED IF RELEVANT INFORMATION BECOMES AVAILABLE.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 8512559 ↗