MAUDE Adverse Event Report: HILL-ROM MEXICO STD STRETCHER FRAME; STRETCHER, WHEELED

Model Number P8005H001144

Device Problem Use of Device Problem (1670)

Patient Problem Fall (1848)

Event Date 09/23/2023

Event Type  Death  

Manufacturer Narrative

It was reported that on the (b)(6) 2023, a 74-year-old male patient, (1.79 m, 84 kilos) in a state of mental confusion (delirium), was placed on a hillrom stretcher in the hospital's emergency room awaiting to be transferred to the icu.The customer stated the staff placed pillows between the patient and the stretcher's side rail to improve comfort and support.The patient made a spontaneous lateral decubitus position change, leaned on the side rail, resulting in the side rail lowering itself and the patient falling onto the floor on their head.The patient suffered facial fractures and body bruises as a result of the fall, his condition deteriorated, and he passed away within a week.The cause of death, the patient's personal data, including previous medical history, admitting diagnosis, etc.Were not provided because of data protection.It was also reported the customer believes that when the staff placed the pillows against the side rail, it did not lock properly, and it became loose.The event occurred within 5 minutes in which the patient was left unattended by the nursing technician.There was no report of device malfunction.Clinical engineering representatives and the nurse responsible for the emergency care area also agreed that there was no equipment failure.The hillrom¿ transport, procedural, and specialty stretchers are intended for caregivers to use for the treatment and transportation of patients in all areas of the hospital, surgical centers, and other patient care facilities.There are no known contraindications for these stretchers when used in accordance with this instruction for use.In regard to siderails, restraints and patient monitoring, the device's ifu states: "warning: warning¿evaluate patients for entrapment risk according to facility protocol and monitor patients appropriately.Make sure all siderails are fully latched when in the raised position.Failure to do either of these could cause serious injury or death.Note: siderails are intended to be a reminder to the patient of the stretcher's edges, not a patient-restraining device.When appropriate, hill-rom recommends that medical persons determine the correct methods necessary to make sure a patient remains safely on a stretcher.Warning: when you raise or lower a siderail, make sure that the area around the siderail is free of objects and devices." [.] "when you raise the siderails, a click lets you know the siderails are completely raised and locked in position.Once the click is heard, gently pull on the siderail to make sure it is latched into position." a search of the baxter maintenance records did not show baxter performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.In this event, the reported patient fall was contributed to the use of the hillrom stretcher.The severity of the injuries suffered by the patient (facial fractures and body bruises) cannot be determined at this time, but it is reasonable to conclude that medical or surgical intervention was required to preclude permanent impairment of a body function or permanent damage to a body structure, which concludes that a serious injury occurred in the reported event.The cause of the patient death was not provided by the customer; however, it cannot be excluded that the reported patient fall has contributed to it.Additionally, no malfunction was found with the device as also confirmed with the customer's representatives.The ultimate cause cannot be determined; however, based on the information provided the reported event was likely due to use error/ misuse of the device (failure to lock the siderail in position and use of pillows between the patient and the siderail).Prevention of this type of events is outlined in the device's ifu as noted above.If any additional relevant information is received, the complaint will be reassessed, and the event will be categorized accordingly.Based on this information, no further action is required.

Event Description

It was reported that on the (b)(6) 2023, a 74-year-old male patient, (1.79 m, 84 kilos) in a state of mental confusion (delirium), was placed on a hillrom stretcher in the hospital's emergency room awaiting to be transferred to the icu.The customer stated the staff placed pillows between the patient and the stretcher's side rail to improve comfort and support.The patient made a spontaneous lateral decubitus position change, leaned on the side rail, resulting in the side rail lowering itself and the patient falling onto the floor on their head.The patient suffered facial fractures and body bruises as a result of the fall, his condition deteriorated, and he passed away within a week.The cause of death, the patient's personal data, including previous medical history, admitting diagnosis, etc.Were not provided because of data protection.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: STD STRETCHER FRAME
• Type of Device: STRETCHER, WHEELED
• Manufacturer (Section D): HILL-ROM MEXICO; ave.del telefono no. 200 col. huinala; apodaca, nuevo leon 66640 ; MX 66640
• Manufacturer Contact: maritza valencia ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 18004344
• MDR Text Key: 326499597
• Report Number: 3006697241-2023-00117
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 00887761000964
• UDI-Public: 010088776100096411181128
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K961437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: P8005H001144
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: No
• 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): Death
• Patient Age: 74 YR
• Patient Sex: Male