[146836946]
On (b)(6) 2019, baby was out of bed setting in specialty stroller provided by pt and nursing wanted to put baby back to bed. Two nurses to return pt to bed with lever pulled that had red tape attached which the nurse thought was the brake which caused the stroller seat is release and lunge forward followed by the infant sliding out of the safety belt and falling to the floor (second nurse attempted to stop the fall and did break some of the fall but unsure if head got hit). Post fall eval showed no injuries. Stroller removed from service. Discovered specialty stroller was brought to unit for pt by pt and vendor and appropriate education was not provided to staff. However, there are serious, high level concerns regarding the design of this stroller pertaining to the handle / release that is attached to the outer stroller handle that allows the seat of the stroller to be manipulated / tilted and the lack of identifiers to this handle and the brake of the stroller. There is a pin that is supposed to be a safety device that can easily be pulled out by anyone (including a child) and concerns the safety pin could work its 'way out by its' self with vibration etc. There is no hairpin on the other side of the safety pin to lock the pin into place. This still would leave a concern that if there was even a hair pin to lock the safety pin in place, it could also be removed by anyone (including a child). There is not enough high risk caution, attention grabbing info near or on this handle / release on the stroller (like a bag attached to the handle specifically with attention grabbing lettering, etc). The brake on this stroller is on the opposite side of the stroller handle which is black in color and has the word "brake" molded into the handle, however this blends right into the handle and is very easily missed as being marked as a "brake. " the brake is not marked in attention grabbing like red and there is not enough high risk caution, attention grabbing info near this brake on the stroller (like a tag attached to the handle specifically with attention grabbing lettering etc). The parents of this child have the same concerns as the healthcare staff regarding this stroller and have a (b)(6) y/o child in addition to this child and their (b)(6) y/o child could easily access this handle / release that manipulates /tilts the stroller seat and also the identifier used for the brake on the opposite side of the stroller. This stroller has been removed from service and will not at this time be used for pts within this health care system due to the significant safety concerns with the design. Distribution center of mfr, sunrise medical, has been notified of the event and the safety concerns by the vendor rep (vendor: (b)(4)) in pennsylvania. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5