MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. CONCERTO + BASIC

Model Number BAB1000-01

Device Problems Inadequate Service (1564); Use of Device Problem (1670)

Patient Problems Fall (1848); Injury (2348)

Event Date 01/21/2015

Event Type  malfunction  

Event Description

It was reported by the company representative that a (b)(6) female resident fell out of a concerto shower trolley during bathing procedure and had to be sent to the hospital.The resident received bump in the forehead, had ct scan/x-rays (went to er); no other info was released.The device was checked by the arjohuntleigh technician visiting the site who found that locking mechanism springs into place and locks stretcher properly, but it is difficult to unlock, part needed to pull lock is missing.

Manufacturer Narrative

(b)(4).When reviewing similar reportable events we have found a number of the complaints with similar fault description (stretcher not closed properly).Taking into consideration that over (b)(4) concertos have been sold 1996, the complaint ratio is considered to be low.From the info obtained via the technician visiting the site, it is indicated the tilting locking mechanism at some point was not working properly, despite there being no issue in closing the stretcher in place it was difficult to open the mechanism as lever needed to be pulled to release it was missing.This means that the concerto/basic device was not up to spec when the event took place.The device was being used for pt handling and in that way contributed to the event.A complete investigation was performed and has identified the following: the stretcher tilting mechanism function of this product, makes it possible and easier to clean the device.The locking mechanism is placed below the stretcher.To tilt the stretcher for cleaning purposes this mechanism has to be unlocked and after the cleaning and before use it should be locked and checked to be locked, as indicated in the instructions for use (ifu).Looking at the incident description we can assume that it is likely that the caregivers made an error in not locking the mechanism, and this directly contributed to the reportable event as later in use the stretcher tilted with a pt on it.The text below is taken from instruction for use (04.Ba.02/5us,ca from 11/2004) which would be delivered this device: "warning: make sure that the catch has locked (click sound) the stretcher after putting it back in place." therefore it appears from our eval that a number of use errors caused the event.The most relevant use error is related with the failure to lock the stretcher in combination with wrong pt position on the device as it is stated in the instruction for use and this directly contributed to the reportable event.We have not been able to find any contributing manufacturing anomalies.The root cause of the complaint was found to be an use error as the received info and our eval as described above are showing that if the ifu safety warnings are followed there will be no pt or caregiver risk.(b)(4).

• Brand Name: CONCERTO + BASIC
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. wawrzyniaka 2; komorniki 6205 2; PL 62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. piotra wawrzynlaka 2; komorniki 6205 2; PL 62052
• Manufacturer Contact: pamela wright ; 12625 wetmore; ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4536500
• MDR Text Key: 5518319
• Report Number: 3007420694-2015-00030
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Nurse
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 02/11/2015,01/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BAB1000-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/11/2015
• Device Age: 6 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 02/11/2015
• Date Manufacturer Received: 01/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR