MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. ROTOPRONE; BED, PATIENT ROTATION, POWERED

Model Number 209500

Device Problem No Apparent Adverse Event (3189)

Patient Problems No Consequences Or Impact To Patient (2199); Low Oxygen Saturation (2477)

Event Date 07/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusion of the investigation.

Event Description

A customer called to arjo representative - a linc operator ( linc-a 24h phone available for rotoprone users) stating that the screen is showing error.The linc operator advised to place the surface to supine to reset the bed.Because the patient remained too unstable to move to supine position, the facility decided to manually turn the bed surface only to various angles on left side.The patient tolerated only left side position, since in supine or on right side the oxygen saturation level was dropping to 0-30.We report this event in abundance of caution taking into account low oxygen saturation level and limited information provided.

Manufacturer Narrative

This appears to be a "malfunction" type of event (h1) not because there was an actual technical malfunction of the device (we found no evidence of it), but since the information initially received could be interpreted as the device not having performed as intended.Arjo received calls from the customer stating that the rotoprone bed was displaying alarm "move patient to zero-degrees supine and call service." according to the nurse, they pulled the red lever from manual rotation earlier.During the call, the customer was advised to reset the bed surface in order to correct the alarm, however the patient did not tolerate supine or right side position since patient oxygen saturation level was dropping to 0-30.The patient was rotated to the left side only.During a following call, a linc operator assisted with correcting the situation, the bed was working properly.No further information about patient outcome was provided.According to an arjo technician alarm, to move the surface to 0 degree supine position, occurs when manual rotation is used and then the bed is not reset properly so that the lock pin cannot be inserted all the way into the slot.The bed senses that the surface is not in zero degree and warns caregivers to correct the situation.The bed is equipped with automatic cpr button located either on the main display or the red and white button located on the front of the unit.The manual cpr refers to engagement of emergency release handle and manual rotation lever.The caregivers stated that before alarm occurred they pulled the red lever from manual rotation.This confirms the root cause assessment for alarm condition provided by the service technician.Initially, this complaint was deemed reportable due to information that the patient's health condition was serious.However, after reviewing all the information gathered, it was concluded that the complaint does not indicate that the rotoprone bed contributed to low saturation level, the complaint simply stated that when the patient was on the right side or supine that the oxygen saturation went to 0-30.Because of patient condition, the bed could not be turned to supine to correct the alarm and initiate automated proning.Please note, that for patients who have little to no oxygenation reserves, movement of the patient to the supine position can result in physiologic decompensation, primarily driven by abrupt changes in blood oxygen saturation resulting in hypoxemia.This is a condition which occurs in association with prone positioning, irrespective of whether that is achieved with the rotoprone therapy system.When this condition occurs, all efforts are made to minimize the need for supine positioning due to the severity of the physiologic decompensation often associated.Regardless of the alarm it was possible to rotate the bed manually to right or left and kept the bed surface at desire angle (it can be done by inserting the lock pin to lock the bed surface).Alarm did not influence bed movements and did not influence patient condition.When the bed returned to the service center, it was cleaned and quality checked.There was no issue found, the bed was operating properly.In summary, when the event occurred the bed was used for patient treatment and in that way played a role in the event.The rotoprone fail to meet its performance specification from use error.However the alarm was not a root cause of patient desaturation.We reported this event in abundance of caution because of information about the oxygen saturation critical level and inability to gather more information from the customer regarding patient outcome.After reviewing all the information gathered, it has been concluded that the rotoprone bed did not cause or contribute to serious injury of death and is unlikely that if the alarm condition reoccurs it may result in a serious injury or death.Secondary safety feature is still available and patient can be rotated as required.There was no product failure, the alarm is a safety feature which is activated in case the bed senses undesired condition to warn caregivers and to correct the situation.The complaints where alarm condition occurs are not considered safety related.

• Brand Name: ROTOPRONE
• Type of Device: BED, PATIENT ROTATION, POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer (Section G): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer Contact: kinga stolinska ; ul. ks. wawrzyniaka 2; komorniki, 62-05-2, P ; PL 62-052, PL
• MDR Report Key: 7794426
• MDR Text Key: 117563592
• Report Number: 9681684-2018-00074
• Device Sequence Number: 0
• Product Code: IKZ
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 209500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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): Life Threatening; Other