MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP Z O.O CONCERTO; LIFT, PATIENT, NON-AC-POWERED

Model Number BAB1103-01

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/11/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusion of the manufacturer's investigation.

Event Description

Arjohuntleigh received a customer complaint on concerto shower trolley, where it was reported that stretcher started to detach from lifting piston, during use with a patient.The facility staff removed the patient from trolley before complete detachment.According to the provided additional information neither patient nor caregiver sustained any injury.

Manufacturer Narrative

The parts of the involved device, which became damaged due to the event will be returned to the manufacturer for further investigation.Additional information will be provided upon conclusion of the manufacturer's investigation.

Manufacturer Narrative

According to the information obtained after submission of initial report mfr #3007420694-2017-00225 it was confirmed that arjo representative became aware of the reported event on 12-oct-2017, not on 21-nov-2017.Additional information will be provided upon conclusion of the manufacturer's investigation.(b)(4).

Manufacturer Narrative

The parts (lifting piston bolts) which were damaged during the event were visually inspected and sent to supplier for an assessment.On 2018-mar-20 arjohuntleigh has received a technical report, presenting the findings from evaluation.The review of the report is ongoing.Additional information will be provided within the next report.

• Brand Name: CONCERTO
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP Z O.O; ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• MDR Report Key: 7112085
• MDR Text Key: 95791318
• Report Number: 3007420694-2017-00225
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/17/2018

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: Other Caregivers
• Device Model Number: BAB1103-01
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/17/2018
• Distributor Facility Aware Date: 10/12/2017
• Device Age: 2 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 04/17/2018
• Initial Date Manufacturer Received: 11/21/2017
• Initial Date FDA Received: 12/13/2017
• Supplement Dates Manufacturer Received: 10/12/2017; 10/12/2017; 03/20/2018
• Supplement Dates FDA Received: 01/12/2018; 02/09/2018; 04/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other