ARJO BASIC BAB5000-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05055982788144), received between Jun 23, 2022 and Nov 24, 2025 — classified as 2 deaths, 2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2025Unstable; Unstable

  ARJO WAS NOTIFIED OF A MALFUNCTION INVOLVING THE CONCERTO SHOWER TROLLEY. IT WAS REPORTED THAT THE STRETCHER WAS CRACKED. NO INJURIES WERE REPORTED. THE DEVICE WAS TAKEN OUT OF USE AND EVALUATED BY AN ARJO REPRESENTATIVE. ACCORDING TO THE FINDINGS, 2 OUT OF 4 SCREWS CONNECTING THE STRETCHER TO THE FRAME VIA A METAL PLATE HAD FALLEN OUT. THE STRETCHER WAS CRACKED AROUND THE SCREW HOLES. THE STRETCHER WAS SUBSEQUENTLY REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23628580 ↗
• MalfunctionNov 25, 2024Device Fell; Device Fell

  CUSTOMER REPORTED THAT DURING HYGIENE OF THE RESIDENT IN THE SHOWER STRETCHER, WHILE MAKING A POSTURAL CHANGE, THE RIGHT-SIDE RAIL OF THE SHOWER STRETCHER OPENED CAUSING THE RESIDENT TO FALL. THE PATIENT SUSTAINED SKULL AND FACE CONTUSION, SCALP AND NECK CONTUSION.

  Patient problems: Bruise/Contusion; Fall

  MAUDE report 20769937 ↗
• DeathJun 23, 2022Device Fell; Device Fell

  ARJO WAS NOTIFIED ABOUT AN EVENT INVOLVING A CONCERTO SHOWER TROLLEY. THE FOLLOWING INFORMATION WAS GATHERED: AFTER WASHING, THE RESIDENT WAS TRANSFERRED TO THE RESIDENT¿S ROOM WITH THE CONCERTO SHOWER TROLLEY. THE TROLLEY WAS POSITIONED PARALLEL TO THE BED. IT WAS REPORTED THAT THE SIDE RAILS WERE UP. WHILE GETTING DRESSED, THE RESIDENT TURNED TOWARDS THE BED, THE SIDE RAILS ALLEGEDLY LOOSENED AND THE RESIDENT THEN FELL HEAD FIRST ONTO THE FLOOR. AS A CONSEQUENCE, THE RESIDENT SUSTAINED BROKEN RIBS, BROKEN COLLARBONE AND THERE WAS MINIMAL BLEEDING. IT WAS REPORTED THAT THE RESIDENT DIED 5 DAYS AFTER THE EVENT.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 14787179 ↗
• DeathJun 23, 2022Device Fell; Device Fell

  ARJO WAS NOTIFIED ABOUT AN EVENT INVOLVING A CONCERTO SHOWER TROLLEY. THE FOLLOWING INFORMATION WAS GATHERED: AFTER WASHING, THE RESIDENT WAS TRANSFERRED TO THE RESIDENT¿S ROOM WITH THE CONCERTO SHOWER TROLLEY. THE TROLLEY WAS POSITIONED PARALLEL TO THE BED. IT WAS REPORTED THAT THE SIDE RAILS WERE UP. WHILE GETTING DRESSED, THE RESIDENT TURNED TOWARDS THE BED, THE SIDE RAILS ALLEGEDLY LOOSENED AND THE RESIDENT THEN FELL HEAD FIRST ONTO THE FLOOR. AS A CONSEQUENCE, THE RESIDENT SUSTAINED BROKEN RIBS, BROKEN COLLARBONE AND THERE WAS MINIMAL BLEEDING. IT WAS REPORTED THAT THE RESIDENT DIED 5 DAYS AFTER THE EVENT.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 14787170 ↗