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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB ENTROY

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ARJO HOSPITAL EQUIPMENT AB ENTROY Back to Search Results
Model Number GAB1007-01
Device Problems Component Falling; Unstable
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).

 
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Brand NameENTROY
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 Key4932672
Report Number3007420694-2015-00140
Device Sequence Number1
Product CodeFNG
Report Source Manufacturer
Source Type User facility,Company Representative
Reporter Occupation
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
Date FDA Received07/20/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberGAB1007-01
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/17/2015
Distributor Facility Aware Date06/18/2015
Device Age3 na
Event Location Hospital
Date Report TO Manufacturer07/17/2015
Date Manufacturer Received06/18/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2012
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 07/20/2015 Patient Sequence Number: 1
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