MAUDE Adverse Event Report: SUNRISE MEDICAL PRIVADA MISIONES QUICKIE IRIS; MANUAL WHEELCHAIR

Model Number EIZ4-2

Device Problem Device Tipped Over (2589)

Patient Problems Death (1802); Fall (1848)

Event Date 01/10/2020

Event Type  Death  

Manufacturer Narrative

Sunrise medical's sr.Director of ra/qa spoke with (b)(6) the same day he called in to customer service.It was verified that (b)(6) is an investigator for the state of (b)(6), office of investigations, department of intellectual and development disabilities.This incident was not previously reported to sunrise medical by the care facility.(b)(6) is performing his investigation based on an incident report filed directly to him by the care home (which is a state-run facility).(b)(6) asked the sr.Director of ra/qa if we manufactured this wheelchair and the anti-tippers that were equipped on the wheelchair.He also asked if the anti-tippers would have moved to the current up position (as they were found after the incident).The following was communicated to (b)(6): "yes, we manufactured the anti-tippers and wheelchair.(b)(6) the previous person you spoke with gave me the serial number (b)(4) for the person's wheelchair.We do not sell to any end-users.We assemble the wheelchair according to the specification on the order form; however, we do not customize the fit of the wheelchair for the end user.That is the responsibility of the ordering agency (tennessee didd seating and positioning clinic).All final adjustments are made by the ordering agency based on the specific needs of the individual.I honestly do not know if the anti-tippers would have possibly moved into the current raised position on his chair because of the fall from the lift." end of statement.There were no allegations of malfunction or defect made against the wheelchair.The director of ra/qa also communicated to (b)(6) that this wheelchair is a four years old chair.This means that the purchaser has had this chair in use for four years.Since the anti-tip device is an item that can be changed by anyone at any time, regardless of whatever position we may have set the anti-tip device in when we shipped it out, it could easily have been moved at any time by anyone.The director of ra/qa also advised (b)(6) that he spoke with sunrise medical's r&d manager and he stated that it is possible that the fall could cause the anti-tip device to slide to a higher position if the anti-tip had been adjusted earlier and was not fully locked into place.However, if the device were fully locked into place, it would not be possible for the anti-tip to change its height without actually causing damage to the anti-tips themselves.Since there was no damage to the device reported, it is likely that the anti-tips were set in the raised position for transporting purposes or were not locked into position prior to the incident.(b)(6) inquire about the wheelchair was mainly part of his investigation into the (b)(6) didd seating and positioning clinic.Sunrise medical does not anticipate the wheelchair will be released for inspection/evaluation.However, sunrise medical regulatory did perform a service history search of this wheelchair and found no previous incidents, issues or service orders for this wheelchair.Based on the information gathered, sunrise medical considers this incident to be accidental.However, if and when any new relevant information is provided from the investigation performed by mr.(b)(6), a supplemental report may be filed.No further investigation will be performed by sunrise medical at this time.

Event Description

(b)(6), an investigator from the department of intellectual & developmental disabilities of (b)(6) contacted sunrise medical's customer service department on (b)(6) 2020 and reported that he was investigating an incident that involved a quickie iris tilt in space wheelchair.(b)(6) stated the end user was being unloaded from a van on a wheelchair ramp when the iris wheelchair tipped over backwards causing the wheelchair user to fall onto his head.The end user subsequently passed away from his injuries.

• Brand Name: QUICKIE IRIS
• Type of Device: MANUAL WHEELCHAIR
• Manufacturer (Section D): SUNRISE MEDICAL PRIVADA MISIONES; no. 110 privada industrial; misiones de las californias; tijuana, baja california 22425 ; MX 22425
• Manufacturer Contact: gustavo zambrano ; 2842 business park ave.; fresno, CA 93727 ; 5592942840
• MDR Report Key: 9638944
• MDR Text Key: 176678464
• Report Number: 9616084-2020-00001
• Device Sequence Number: 1
• Product Code: IOR
• UDI-Device Identifier: 05022408048953
• UDI-Public: 05022408048953
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123975
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: EIZ4-2
• Device Catalogue Number: ElZ4-2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/10/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/12/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death