ACCUPULSE SINGLE LUMEN CONSERVING REGULATOR IN6505-L-BLUERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00814470020051), received between May 31, 2017 and May 31, 2017 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fire” (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

Recent adverse event reports

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

• MalfunctionMay 31, 2017Fire; Fire

  IT WAS REPORTED THAT THE CUSTOMER WAS IN A VEHICLE AT THE TIME OF THE INCIDENT AND WAS SWITCHING OVER THE DEVICE FROM AN EMPTY CYLINDER TO A FULL CYLINDER. THE DEVICE WAS CONNECTED AND AFTER TURNING ON THE CYLINDER VALVE, A LEAK WAS NOTICED. THE CYLINDER VALVE WAS TURNED OFF AND RECONNECTED TO THE DEVICE TWO MORE TIMES. ON THE LAST ATTEMPT, A HISS WAS HEARD THAT GOT LOUDER, AND THEN FLASHED WITH A FLAME. THE CUSTOMER JUMPED OUT OF THE CAR AND THEN QUICKLY TURNED THE CYLINDER VALVE OFF TO PREVENT A FIRE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6602668 ↗
• InjuryMay 31, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) (A THIRD PARTY ADMINISTRATOR OF INSURANCE FOR A DURABLE MEDICAL EQUIPMENT (DME) COMPANY) REPORTED THAT (B)(6) (CLAIMANT) WAS REMOVING AN INOVO ACCUPULSE REGULATOR DEVICE FROM AN OXYGEN CYLINDER WHEN THE O-RING BLEW OFF, STRIKING HER IN THE HAND. THE O-RING MENTIONED BY THE COMPLAINANT IS KNOWN AS THE SEAL WASHER AND JOINS SYSTEMS OR MECHANISMS TOGETHER BY PREVENTING LEAKAGE. THE EXPLANATION OF THE EVENT FROM THE ESIS REPORT INDICATES THAT THE ACCUPULSE REGULATOR WAS STILL UNDER PRESSURE WHEN MS. (B)(6) ATTEMPTED TO LOOSEN/REMOVE THE DEVICE FROM THE CYLINDER. THE LOOSENING OF THE REGULATOR CONNECTION FROM THE CYLINDER 870 POST VALVE CAUSED THE IMMEDIATE RELEASE OF HIGH PRESSURE GAS FROM THE OUTLET ORIFICE OF THE OXYGEN CYLINDER. THE HIGH FLOW AND PRESSURE OF GAS ESCAPING FROM THE CYLINDER DISLODGED THE SEAL WASHER FROM THE REGULATOR, AND CAUSED THE LOUD "POP" SOUND DESCRIBED IN THE REPORT. ATTEMPTING TO REMOVE THE REGULATOR WHILE THE CYLINDER IS STILL ON AND UNDER PRESSURE IS IN DIRECT CONFLICT WITH THE GUIDANCE AND WARNINGS IN THE ACCUPULSE USER MANUAL, WHICH STATES 'I WARNING: FAILURE TO CLOSE THE CYLINDER VALVE BEFORE REMOVING THE REGULATOR FROM THE CYLINDER WILL RESULT IN

  Patient problems: Abrasion; Injury

  MAUDE report 6600819 ↗