MAUDE Adverse Event Report: HILL-ROM BATESVILLE TOTALCARE BARIATRIC; BED, FLOTATION THERAPY, POWERED

Model Number P1840DCA000010

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cyanosis (1798); Low Oxygen Saturation (2477)

Event Date 02/14/2024

Event Type  Injury  

Manufacturer Narrative

It was reported that on (b)(6) 2024 at shift change (approximately 23:00h), a patient on a totalcare bariatric bed was found lying flat gasping to breath, face cyanotic, and spo2 at 35%.The patient recovered quickly when the head of the bed was raised, however, patient could have gone pulseless from lack of o2 if she was not found.It was noted that the patient did not put herself flat, the head of the bed fell flat.It was also stated that the bed has been repaired, and a leaky hydraulic valve was found and replaced.The bed was up to date on all scheduled planned maintenance.The totalcare® bariatric bed or totalcare® bariatric plus therapy system is intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from either continuous lateral rotation therapy or percussion/vibration therapy.The totalcare® bariatric bed or totalcare® bariatric plus therapy system is intended to provide a patient support to be used in health care environments.The totalcare® bariatric bed or totalcare® bariatric plus therapy system may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acute sub-acute care, post anesthesia care unit (pacu), and sections of the emergency department (ed).Oxygen desaturation is a below-normal level of oxygen in the blood.Normal pulse oximeter readings range from 94 to 100 percent a value under 90 percent is considered low.Oxygen desaturation can be contributed to disorders such as copd, emphysema, respiratory failure, or other pulmonary disorders.Treatment typically consists of oxygen measurement (via blood test or pulse oximetry) and oxygen administration.In this event, the patient¿s oxygen level was clinically below normal range (35%), the change was temporary, and the patient recovered once the head of the bed was raised and supplemental oxygen was provided.However, the event of oxygen desaturation accompanied by symptoms of inability to breathe and cyanosis, is considered a serious injury.Additionally, the exact cause of the reported event is undetermined at this time.Investigation is on-going, any additional and relevant information received in the course of the investigation will be provided in a supplemental report.

Event Description

It was reported that on (b)(6) 2024 at shift change (approximately 23:00h), a patient on a totalcare bariatric bed was found lying flat gasping to breath, face cyanotic, and spo2 at 35%.This report was filed in our complaint handling system as complaint #(b)(4).

Event Description

It was reported that on (b)(6) 2024 at shift change (approximately 23:00h), a patient on a totalcare bariatric bed was found lying flat gasping to breath, face cyanotic, and spo2 at 35%.This report was filed in our complaint handling system as complaint (b)(4).

Manufacturer Narrative

It was reported that on 2/14/2024 at shift change (approximately 23:00h), a patient on a totalcare bariatric bed was found lying flat gasping to breath, face cyanotic, and spo2 at 35%.The patient recovered quickly when the head of the bed was raised, however, patient could have gone pulseless from lack of o2 if she was not found.It was noted that the patient did not put herself flat, the head of the bed fell flat.It was also stated that the bed has been repaired, and a leaky hydraulic valve was found and replaced.The bed was up to date on all scheduled planned maintenance.The totalcare® bariatric bed or totalcare® bariatric plus therapy system is intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from either continuous lateral rotation therapy or percussion/vibration therapy.The totalcare® bariatric bed or totalcare® bariatric plus therapy system is intended to provide a patient support to be used in health care environments.The totalcare® bariatric bed or totalcare® bariatric plus therapy system may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acute sub-acute care, post anesthesia care unit (pacu), and sections of the emergency department (ed).Oxygen desaturation is a below-normal level of oxygen in the blood.Normal pulse oximeter readings range from 94 to 100 percent a value under 90 percent is considered low.Oxygen desaturation can be contributed to disorders such as copd, emphysema, respiratory failure, or other pulmonary disorders.Treatment typically consists of oxygen measurement (via blood test or pulse oximetry) and oxygen administration.In this event, the patient¿s oxygen level was clinically below normal range (35%), the change was temporary, and the patient recovered once the head of the bed was raised and supplemental oxygen was provided.However, the event of oxygen desaturation accompanied by symptoms of inability to breathe and cyanosis, is considered a serious injury.Additionally, the exact cause of the reported event is undetermined at this time.Investigation is on-going, any additional and relevant information received in the course of the investigation will be provided in a final report.Clinical update with receipt of additional details: the patient¿s oxygen level was clinically below normal range (35%), the change was temporary, and the patient recovered once the head of the bed was raised and supplemental oxygen was provided.However, the event of oxygen desaturation accompanied by symptoms of inability to breathe, cyanosis, and medical intervention provided to preclude permanent impairment of a body function or permanent impairment of a body structure is considered a serious injury.The exact cause of the serious injury is unknown.Upon inspection, the baxter technician found a leaking hydraulic valve, which is not an electrical function starting on its own but rather a valve staying open which may result in the head section drifting down.A drift is a slow and gradual motion over a certain period of time.The bed is equipped with a head of bed angle alarm, however, upon inspection, the baxter technician found the alarm to be functioning as designed.It is reasonable to conclude that the head of bed angle alarm was not set, despite the bed being equipped with the alarm.The exact cause of the event (head of bed lowering) is unknown, however, the serious injury is likely attributed to use error in failure to set the head of bed angle alarm which would have alerted the caregiver in this event.If any additional relevant details are obtained, the complaint will be addressed accordingly.

• Brand Name: TOTALCARE BARIATRIC
• Type of Device: BED, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: kayla miller ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 18895708
• MDR Text Key: 337568145
• Report Number: 1824206-2024-00340
• Device Sequence Number: 1
• Product Code: IOQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K122473
• 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: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: P1840DCA000010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/14/2024
• Initial Date FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/10/2011
• 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
• Patient Sex: Female