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

Model Number 209500

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 08/19/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The investigation has been performed and the conclusions are as followed.When reviewing reportable events for rotoprone device we were able to establish that there have been complaints in the past, which relate to buckle open alarm occurrence, however in comparison to placement date the occurrence rate is considered low.The product involved in the incident is rotoprone, which is a part of the arjohuntleigh us rental fleet.The device was rented to the customer (b)(6).The customer called stating that they could not supine patient and that chest buckle alarm occurred.Upon education provided by a linc operator, who walked the facility through the information displayed on the screen, the issue was solved.Additional information provided was that a patient condition deteriorated.The buckle alarm will occur if the buckle is not secured or if the proning packs are not tight enough to keep the proning arms held tightly against the patient surface during rotation.This alarm is to protect the patient from falling out of the bed or migrating during rotation.The rotoprone device is equipped with two independent systems allowing for the patient surface to rotate, automatic electrical rotation and manual rotation.Even in case of buckle alarm the device can be still operated and if needed patient surface may be placed in prone or supine position.From the complaint description, we have learnt that buckle alarm occurred when a caregiver was trying to place the device from prone to supine position.This would mean that patient weight shifted to one side resulting in prone pack arm not activating the tape switch and in a result buckle alarm was triggered.User manual #208662-ah rev.D, which is delivered to the customer together with the bed, instructs how to properly positioned patient on the device, install side support packs, how to accommodate packs to patient size, it warns that "tightness of pack straps will vary according to each patient's needs.Straps need to be tight as can be tolerated, as patient will shift into the prone packs and away from the patient surface when moved into prone position".To prevent patient shifting, side packs shall be position snugly against patient's sides using pack adjuster crank.As per user manual "side packs need to be tight enough to prevent patient from sliding from side-to-side when rotated".When buckle alarm occurs the information what steps shall be performed to correct the situation are displayed on the bed screen, also user manual provides guidance how to correct the buckle alarm condition.When bed returned to the service centre it was cleaned and inspected per quality control process and no anomalous condition was identified.There was no repair done on the device which would suggest that there was no malfunction, the device was up to manufacturer specification.It is worth mentioning that the device passed quality control check before being placed at a facility and it had its functionality checked during facility setup.On both occasions no fault was identified, all bed functions operated correctly.Taking the above into consideration: buckle alarm occurrence when patient was attempting to be place in supine, no malfunction found within device, it can be stated that the buckle alarm occurrence was most likely related to the insufficient side packs tightening and not to the device malfunction.In summary, the device was being used for treatment at the time of the event and therefore was directly involved in the event.In the course of the investigation it was found that the device was up to manufacturer's specification.The buckle alarm occurred in a result of use error - not sufficient side packs tightening.Although prone therapy brings benefits to the patient, it may also pose a risk.According to ']memo to file.Risk/ benefit analysis associated with rotoprone¿ risk assessment': "for patients who have little to no oxygenation reserves, movement of the patient to the supine position can result in a significant physiologic decompensation, primarily driven by dramatic and 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." user manual warns that caregivers shall discuss risk and precautions of using rotoprone therapy system with the patient and the patient's family.The information was that the patient condition deteriorated.Although no specific information regarding to what extend the patient condition deteriorated and what was the patient condition before placing on the rotoprone was provided, we report this incident in abundance of caution as a serious injury cannot be excluded.Arjohuntleigh does not suggest any actions at this moment but shall continue to monitor for any further events of this nature.

Event Description

A nurse called stating that they could not supine patient and that chest buckle alarm occurred.Issue was resolved by education.A linc operator provided instruction how to resume therapy by following the instruction displayed on the screen and patient surface could be turn to supine.Additional information provided was that a patient condition deteriorated.No additional information was provided by the linc operator apart from that the nurse did not provided a call back number.

• 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 ; 698282467
• MDR Report Key: 6587526
• MDR Text Key: 75855964
• Report Number: 3007420694-2017-00115
• Device Sequence Number: 1
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/24/2017

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 Operator: Health Professional
• Device Model Number: 209500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2016
• Initial Date FDA Received: 05/24/2017
• 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): Other