MAUDE Adverse Event Report: ARJO HOSP EQUIPMENT AB ENTROY

Model Number GAB1000-01-GB

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problems Fall (1848); No Known Impact Or Consequence To Patient (2692)

Event Date 12/22/2014

Event Type  malfunction  

Event Description

Initially it was reported by arjohuntleigh rep that seat detached during use.The resident was lifted out of the pool on the entroy's chair.When the caregiver transferred the chair onto the chassis, the handle clicked in and showed green, then the chair including the base toppled over, including the base, with a resident in it, the chair came away from the base.Device condition has been described as satisfactory "for the age of machine".Function test performed with the customer showed that all functions were working ok on the device," especially the locking mechanism".The svc tech checked the chair unit on the entroy and the chair several times, each time this locked into place was designed.From this info we can state that the device met its spec.Arjohuntleigh's rep informed also about possibility of re-creating the reported event: "if the locking mechanism was in the read section, then the chair is able to swing out approx 45 degrees from the chassis and become very unstable and could easily topple over." however this situation is outside the normal use of the device.

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 where seat or stretcher detached from entroy's lifting arm or base.Complaint rate concerning above reportable events is very low and decreasing.Please note that arjohuntleigh mfg about (b)(4) entroys to date.The device was inspected by an arjohuntleigh rep at the customer site and found to be to the spec - no fault was found.The device was being used for pt handling and in that way contributed to the event.The service tech checked the chair unit on the entroy and the chair several times, each time this locked into place as designed.From this info we can state that the device met its spec.Device examination did not reveal any malfunction that could have led to the reported event.As stated by the svc tech "all functions were working ok on the machine, especially the locking mechanism".From the rec'd info we can stat that the complained device met its spec.However further device examination showed that it was possible to re-create the reported incident: "chair is able to swing out approx 45 degrees from the chassis and become very unstable and could easily topple over".The svc tech made a comment regarding this situation where it was indicated that the problem is related to user error:"the only explanation that i can see for the chair to swivel 45 degrees from the chassis and also become detached from the chassis, is if the chair hadn't been locked onto the chassis during transfer".Info included in incident description form showed that the chair swivelled 45 degrees from the chassis and detached from it.The only explanation why this happened is incorrectly docked chair.This was also communicated by the svc tech as stated above.The most possible cause why chair.

• Brand Name: ENTROY
• Manufacturer (Section D): ARJO HOSP EQUIPMENT AB; verkstadsvagen 5; eslov 2412 1; SW 24121
• Manufacturer (Section G): ARJO HOSP EQUIPMENT AB; verkstadsvagen 5; eslov 2412 1; SW 24121
• Manufacturer Contact: pamela write ; 12625 wetmore; ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4591513
• MDR Text Key: 21333558
• Report Number: 3007420694-2015-00056
• 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: 02/11/2015

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?: No
• Device Operator: Other
• Device Model Number: GAB1000-01-GB
• 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: 03/09/2015
• Distributor Facility Aware Date: 02/11/2015
• Device Age: 4 YR
• Event Location: Other
• Date Report to Manufacturer: 03/09/2015
• Initial Date Manufacturer Received: 02/11/2015
• Initial Date FDA Received: 03/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2011
• 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: 127