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

Model Number BAB5000-01

Device Problems Break (1069); Inadequate Service (1564); Detachment of Device or Device Component (2907)

Patient Problems Bruise/Contusion (1754); No Consequences Or Impact To Patient (2199)

Event Date 02/11/2015

Event Type  malfunction  

Event Description

It was reported by the customer that while giving a bath to the resident on the concerto shower trolley, the stretcher tilted.Pt was not injured.Caregiver prevented pt from falling but received a bruise on upper left shoulder.Arjohuntleigh tech was visiting the site after the incident to perform interview and device eval.It was found that the stretcher tilted due to the stretcher being broken at the screws attachment and missing screws.Gen condition of the device was estimated as fair (broken stretcher and worn mattress).During the inspection operating manual and preventive maintenance were not available for users.The device was not under arjohuntleigh service contract and had its maintenance performed by the customer, but preventive maintenance schedule was not available.The date of the last maintenance was not provided.Tech recommended that the customer check the stretcher screws on another 9 devices.

Manufacturer Narrative

(b)(4).(b)(4).

• Brand Name: CONCERTO + BASIC
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki; poznan 6205 2; PL 62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki; poznan 0000 6205; PL 000062052
• Manufacturer Contact: pamela wright ; 12625 westmore ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4611495
• MDR Text Key: 17331310
• Report Number: 3007420694-2015-00058
• 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
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 03/13/2015,02/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BAB5000-01
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/13/2015
• Distributor Facility Aware Date: 02/13/2015
• Device Age: 7 NA
• Event Location: Nursing Home
• Date Report to Manufacturer: 03/13/2015
• Date Manufacturer Received: 02/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2008
• 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: 48 YR
• Patient Weight: 74