MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB ENTROY

Model Number GAB1007-01

Device Problems Component Falling (1105); Unstable (1667)

Patient Problems Fall (1848); Head Injury (1879)

Event Date 05/27/2015

Event Type  malfunction  

Event Description

Initially it was reported by arjohuntleigh representative that seat partially detached during use."during the transfer from swimming pool to the wheelchair, the hoist chair was partially broken and the patient fell down in the water and bumped the neck and shoulder.The patient was restrained by the security armband." the resident sustained head and shoulder trauma, however no hospitalization was required.Only examination was needed, with no medical intervention.

Manufacturer Narrative

(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, concerning failure of docking mechanism.There is decreasing complaint trend for this issue and no trend for complaint on failure of docking in use with patients.The device was being used for patient handling and in that way contributed to the event.The device examination revealed in finding of malfunction - missing one of springs in locking catch.The rec'd information showed that lack of this part did not affect the device indicator of correct docking and it could only affect handle movement, therefore we don't find this malfunction to be the cause of the reported event.Nevertheless the involved device failed to meet its spec.Please note also that it was not possible to re-create the reported event by the arjohuntleigh service technician.The most likely cause of seat partial detachment is incorrect docking onto lifting arm, which is in line with findings for previous similar complaints.From our eval and the rec'd information, user error cannot be ruled out.See scanned page.No training details were provided for involved staff.From the above we can conclude that the incident was most probably caused by an user error - user didn't followed warnings regarding correct docking and preserving patient's safety.The rec'd information and our eval as described above are showing that if entroy's warnings and transferring procedures would be followed, in accordance to instructions for use, there would be no patient or caregiver at risk.(b)(4).

• Brand Name: ENTROY
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov ; SW
• Manufacturer (Section G): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 2412 1; SW 24121
• Manufacturer Contact: pamela wright ; 12625 wetmore; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 4932672
• MDR Text Key: 6051883
• Report Number: 3007420694-2015-00140
• Device Sequence Number: 1
• Product Code: FNG
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 07/17/2015,06/18/2015

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?: Yes
• Device Operator: Health Professional
• Device Model Number: GAB1007-01
• 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: 07/17/2015
• Distributor Facility Aware Date: 06/18/2015
• Device Age: 3 NA
• Event Location: Hospital
• Date Report to Manufacturer: 07/17/2015
• Initial Date Manufacturer Received: 06/18/2015
• Initial Date FDA Received: 07/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2012
• 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: 63 YR