MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. MIRANTI; FSA

Model Number CEB8003-01

Device Problem Component Falling (1105)

Patient Problem Syncope (1610)

Event Date 01/13/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The instruction for use 04.Ce.02_13us.Ca from june 2012 informs for the following: "the parts of the stretcher are secured by the enclosed sling when the parts are folded upwards.See illustration below.The stretcher parts are heavy!" there is also a drawing showing how it should be stored with a sling not allowing the parts of the stretcher to fall down.The device was inspected by the arjohuntleigh service technician, who found the device working to the manufacturer specification.Therefore it appears there has been no technical deficiency with the device and that a use error and unfortunate circumstances caused the event.The device evaluation and conclusions from the investigation shows that there was no fault of the device, rather the incident was a result of wrong device storage and not being careful when moving equipments.Looking at the incident scenario it has been established that incorrect storage of the hygiene chair (miranti) has contributed to the event.If the instructions included in ifu would have been followed there would not be anyone at risk and the event would have been avoided.

Event Description

Miranti is a device on which the patient lies to be bathed in the tub.For the purpose of storage, the devices stretcher can be folded to save the space in the storage by lifting head and leg parts of the stretcher up and tying them together by a strap.It was reported by the customer that the miranti was stored with the stretcher parts lifted in the upright position without the securing strap being attached - which would keep the parts in a secure position.The staff member who was in the storage, moved another piece of equipment beside the miranti which was inadvertently supporting the raised section.When this happened one side of the miranti fell down and hit the staff person on the head knocking him out.The facility indicates that the miranti was not at fault and that the cause of the incident was the improper folding of the miranti without using the securing strap, which caused stretcher part to fall on the staff member.The facility has already changed the way of the miranti is store to prevent an incident like this from occurring again.

• Brand Name: MIRANTI
• Type of Device: FSA
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ks wawrzyniaka 2; komorniki, PL 62 -052; PL PL 62-052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ks wawrzyniaka 2; komorniki, PL 62 -052; PL PL 62-052
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 5406440
• MDR Text Key: 37386002
• Report Number: 3007420694-2016-00013
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 02/03/2016,01/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: CEB8003-01
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/03/2016
• Distributor Facility Aware Date: 01/20/2016
• Device Age: 4 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 02/03/2016
• Date Manufacturer Received: 01/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2012
• 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