CARDINAL HEALTH 68-8888Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885380153204), received between Mar 15, 2022 and Mar 15, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “No Audible Alarm” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 15, 2022No Audible Alarm; Suction Failure; No Audible Alarm; Suction Failure

  CUSTOMER REPORT INDICATED THAT THE MOTOR ON THE DEVICE WAS NOT RUNNING WHEN THE CANISTER WAS REMOVED, HOWEVER THE UNIT STILL HAD PLENTY OF THERAPY TIME REMAINING. THE UNIT TECH WAS UNSURE IF THE DRESSING WAS SEALED AND DEPRESSED WHILE ON THE PATIENT. THE DEVICE WAS TESTED ONCE IT WAS RETURNED TO THE UNIT¿S DEPARTMENT. TESTING CONFIRMED THAT THERE WAS NO SUCTION. UNIT TECH WAS UNSURE IF THE DEVICE SOUND SETTING WAS CHANGED WHEN IT WAS USED BUT CONFIRMED THAT THE DEVICE DID NOT ALARM WHEN THEY TESTED THE UNIT. THERE WAS NO INJURY TO PATIENT AND PATIENT IS DOING FINE AND IS STILL USING THE BACKUP DEVICE PROVIDED BY THE FACILITY.

  MAUDE report 13764911 ↗