MAUDE Adverse Event Report: PERMOBIL SEATING AND POSITIONING OBSS TRU-SHAPE

Model Number 6364920

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem Respiratory Distress (2045)

Event Date 09/04/2018

Event Type  Injury  

Manufacturer Narrative

While the mother alleges that the device contributed to an adverse event, we were not provided any documentation to substantiate that claim.If additional information is received, a final report will be submitted at that time.

Event Description

As reported by mother and caregiver: event description: "this form is being filled out by mother/full time caregiver of patient.After 4 long months of waiting for the first fit of the seating system, we had an appointment on (b)(6) 2018.The seat was brought home.Within an hour or so, my daughter started to have breathing difficulty.I noticed when i walked into her room that there was a strong chemical smell.I knew right away it was the seating system.I had to quickly suction out her lungs.After i got the mucus plug out of her lung & got her on her bed & out of her seat, i hooked her up to her ventolin machine.I rushed the seat out of the house and left it out.I contacted the ot at seating on (b)(6) but seating clinic was not open.I dug an old system out of our basement because our daughter's previous seating system was at the hospital.I contacted (b)(4) (permobil) (b)(4)'s rep.He contacted me immediately.Follow up meeting was set up on (b)(6) 2018.He arranged for a (b)(6) meeting with (b)(6) in (b)(6).Ot, pt both could smell the seat when they made an impression in the seat.All agreed that the smell was really bad.It was also agreed with (b)(6) & (b)(6) that there would be a new seat made that would not be sprayed and only covered.I also asked for an additional cover for the seat.Long story short, chemical smell is not so much noticed in large institutional settings.When the systems are in a home, bedroom etc.The smell is there & strong." detailed consequences: "our daughter suffered a life threatening reaction of her lungs filling up and a large mucus plug that had to be suctioned out of airway.She then had no seating system which she depends on to sit up in her wheelchair." medical treatment required? "yes, lungs filled up and suctioning was needed.Airway was blocking with mucus plug.She has allergies to chemicals and this is the reaction to air born chemicals.".

• Brand Name: OBSS TRU-SHAPE
• Type of Device: OBSS TRU-SHAPE
• Manufacturer (Section D): PERMOBIL SEATING AND POSITIONING; 1130 south 3800 west; salt lake city UT 84104
• Manufacturer (Section G): PERMOBIL SEATING AND POSITIONING; 1130 south 3800 west; salt lake city UT 84104
• Manufacturer Contact: robin gergen ; 100 north florida avenue; belleville,
• MDR Report Key: 8392115
• MDR Text Key: 137883816
• Report Number: 3011208882-2019-00001
• Device Sequence Number: 1
• Product Code: IMP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: 6364920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention