CONCERTO BAB1000-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05055982788083), received between Aug 28, 2019 and Mar 18, 2025 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Fell” (3 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2025Device Fell; Device Fell

  ARJO WAS NOTIFIED OF AN EVENT RELATED TO A CONCERTO SHOWER TROLLEY. IT WAS REPORTED THAT A PATIENT FELL FROM THE DEVICE AS THE SIDE SUPPORT OPENED. THE PATIENT SUSTAINED HEAD INJURY BUT NO MORE DETAILS REGARDING THE PATIENT'S TREATMENT WERE RELEASED BY THE FACILITY.

  Patient problems: Fall; Head Injury

  MAUDE report 21629246 ↗
• MalfunctionNov 16, 2022Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  ARJO WAS NOTIFIED ABOUT AN EVENT WITH INVOLVEMENT OF THE CONCERTO/BASIC SHOWER TROLLEY. IT WAS REPORTED THAT A PATIENT FELL FROM THE DEVICE WHILE SHOWERING. AS A CONSEQUENCE THE PATIENT SUSTAINED A BUMP. IT WAS INDICATED THAT ONE OF THE CATCHES DOES NOT HOLD THE SIDE SUPPORT IN PLACE. THIS CAUSES THE SIDE SUPPORT TO BEND AT THE BOTTOM. AS A RESULT, THE SIDE PANEL IS ONLY WELL FIXED ON ONE SIDE (IN THE UPPER PART).

  Patient problems: Fall

  MAUDE report 15803765 ↗
• InjurySep 8, 2021Unintended System Motion; Unintended System Motion

  ARJO WAS NOTIFIED ABOUT AN EVENT WITH INVOLVEMENT OF THE CONCERTO/BASIC SHOWER TROLLEY. IT WAS REPORTED THAT WHEN THE CAREGIVER TURNED HER BACK TO THE PATIENT TO THROW AWAY THE DIAPER THE STRETCHER TILTED AND THE PATIENT FELL TO THE GROUND. THE PATIENT'S FALL WAS DAMPENED BY THE SIDE RAIL BEFORE FALL TO THE GROUND. THE PATIENT SUSTAINED SCRATCHES ON HIS KNEES AND WRISTS. HE WAS CHECKED BY A DOCTOR AND THERE WAS NO FRACTURE NOR SPRAIN FOUND. THE STRETCHER WAS IN VERTICAL POSITION BEFORE USE. THE CAREGIVER PUT THE STRETCHER TO THE HORIZONTAL POSITION BEFORE THE PATIENT WAS PLACED ON IT. THE PATIENT WAS LATERALIZED ON HIS LEFT SIDE TO CHANGE HIM.

  Patient problems: Abrasion; Fall

  MAUDE report 12437605 ↗
• InjuryJul 26, 2021Device Fell; Device Fell

  ARJO WAS INFORMED ABOUT AN INCIDENT WITH INVOLVEMENT OF A CONCERTO SHOWER TROLLEY. IT WAS REPORTED THAT THE RESIDENT FELL OUT ON THE FLOOR, WHEN THE SIDE SUPPORT UNLOCKED AND MOVED TO LOWER POSITION. THE PATIENT WAS IN PAIN, HAD A SWOLLEN KNEE AND WAS TAKEN TO THE EMERGENCY ROOM FOR AN X-RAY. IT WAS CONFIRMED THAT PATIENT SUSTAINED THE FEMORAL FRACTURE.

  Patient problems: Limb Fracture

  MAUDE report 12224664 ↗
• InjuryJul 26, 2021Device Fell; Device Fell

  ARJO WAS INFORMED ABOUT AN INCIDENT WITH INVOLVEMENT OF A CONCERTO SHOWER TROLLEY. IT WAS REPORTED THAT THE RESIDENT FELL OUT ON THE FLOOR, WHEN THE SIDE SUPPORT UNLOCKED AND MOVED TO LOWER POSITION. THE PATIENT WAS IN PAIN, HAD A SWOLLEN KNEE AND WAS TAKEN TO THE EMERGENCY ROOM FOR AN X-RAY. IT WAS CONFIRMED THAT PATIENT SUSTAINED THE FEMORAL FRACTURE.

  Patient problems: Limb Fracture; Swelling/ Edema

  MAUDE report 12224653 ↗
• MalfunctionAug 28, 2019Fracture; Fracture

  ARJO WAS REQUESTED BY THE CUSTOMER FACILITY TO PERFORM SERVICE DUE TO FINDING 2 BROKEN SIDE SUPPORT SAFETY CATCHES. NO PATIENT INVOLVEMENT OR INJURY OCCURRENCE WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8939886 ↗