MAUDE Adverse Event Report: ARJO HUNTLEIGH CONCERTO; SHOWER TROLLEY

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Fall (1848)

Event Date 07/21/2014

Event Type  malfunction  

Event Description

Pt rolled off of a concerto shower trolley during care, falling to the floor.Pt was transferred 911 from (b)(6) to acute care hospital as a result.It appears that one of two spring loaded clips that hold the shower trolley side rail in place was not properly engaged.Upon investigation we found that with a single clip engaged, and with some weight applied, the rail will drop inadvertently.We were also able to replicate a single clip being engaged with several test demonstrations.All clips and springs appeared to be in good condition and good working order; however, it was rather easy to re-create single clip engagement.It was also concerning that it would be easy for this to go unnoticed by the caregiver because the clips are visually obscured by the presence of the shower bed cover that covers both rails and the shower trolley base.

• Brand Name: CONCERTO
• Type of Device: SHOWER TROLLEY
• Manufacturer (Section D): ARJO HUNTLEIGH; neptunigatan 1
• MDR Report Key: 4006258
• MDR Text Key: 4711977
• Report Number: MW5037713
• Device Sequence Number: 1
• Product Code: ILJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/22/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 58