MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB ENTROY; FNG

Device Problem Detachment Of Device Component (1104)

Patient Problems Fall (1848); Pain (1994)

Event Date 09/24/2014

Event Type  malfunction  

Event Description

Initially it was reported by arjohuntleigh rep that stretcher detached from pool lift during use.The patient was strapped in to the stretched attachment of the hoist and removed from the pool without any problems.The stretcher was then transferred from the hoist's docking point to the transporter for showering.The stretcher was docked, the locking handle appeared engaged to the operator, so the transporter was turned to the left towards a shower unit.During this turning maneuver the stretcher became detached from the transporter, falling directly on to the floor.As a result of this incident twinges were felt in lower back area by the resident.The resident was observed by gp, no other injury occurred.General condition of complained device was described in incident description form as good.Function test showed that hoist operates correctly, device did not fail to meet its specification.It was not possible to re-create this event by arjohuntleigh rep.Last maintenance was performed in (b)(6) 2014, date of last training to caregivers was not provided, it has been described only as ongoing.

Manufacturer Narrative

This report is being filed under exemption (b)(4) by arjo hosp equipment (b)(4) on behalf of the importer arjohuntleigh, inc.(b)(4).An investigation was carried out into this complaint.When reviewing similar reportable events for entroy we have found a low number of other similar cases where seat or stretcher detached from entroy's lifting arm.Complaint rate concerning above reportable events is very low and decreasing.Please note that arjohuntleigh manufactured about (b)(4) entroys to date.The device was inspected by an arjohuntleigh rep at the customer site and found to be to the specification - no fault was found and it wasn't possible to recreate this event.The device was being used for patient handling and in that way contributed to the event.As a result of this incident twinges were felt in lower back area by the resident.The resident was observed by gp, no other injury occurred.Info included in incident description form showed that event occurred while "the transporter was turned ot the left towards a shower unit.During this turning manoeuver the stretcher became detached from the transporter, falling directly on to the floor".It can be concluded that stretcher detached as it wasn't correctly secured to the chassis and the caregiver didn't checked it.The most possible cause of it is lack or insufficient training, as no info about date of last training was provided.Arjohuntleigh rep informs only in incident description form that training for involved caregivers in ongoing.Please note also that no fault was found with a device that could contribute to this event and function test showed that device met its specification.From above we can concluded that this problem was caused by user error-user didn't followed warnings regarding correct docking and preserving patient's safety.The received info and our evaluation as described above are showing that if entroy's warnings and transferring procedures were followed in accordance to instruction for use and, there would be not patient or caregiver at risk.(b)(4).

• Brand Name: ENTROY
• Type of Device: FNG
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 2412 1; SW 24121
• Manufacturer (Section G): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov ; SW
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4189662
• MDR Text Key: 5100851
• Report Number: 9611530-2014-00081
• Device Sequence Number: 1
• Product Code: FNG
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 09/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/17/2014
• Distributor Facility Aware Date: 09/24/2014
• Event Location: Nursing Home
• Date Report to Manufacturer: 10/17/2014
• Initial Date Manufacturer Received: 09/24/2014
• Initial Date FDA Received: 10/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2008
• 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 Weight: 60