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 Low Oxygen Saturation (2477)

Event Date 12/14/2016

Event Type  Injury  

Manufacturer Narrative

Please note that this product is no longer manufactured and previous medwatch reports for this product may have been submitted for the manufacturing site kinetic concept inc (under registration #1625774).From november 2012 until 2014 complaints related to this product were handled by arjohuntleigh inc, and any medwatch reports were submitted under registration #3009988881.From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh (b)(4)'s complaint handling establishment and any medwatch reports will be submitted under registration #307420694.The investigation has been performed and the conclusions are as followed: the product involved in the incident is a rotoprone therapy system serial number: (b)(4).The device is part of the arjohuntleigh us rental fleet.The device was rented to the customer (b)(6) university medical center.The customer called stating that the patient was placed in supine position, the oxygen saturation was dropping and the nurse was not able to automatically rotate the device due to buckle alarm, which indicated that lower prone pack is not secured.An arjohuntleigh representative who responded to the call, advised to ensure that the sensor was free from obstruction and proning pack was secured.The alarm could not have been cleared, patient remained unstable.Staff was instructed to place the device in prone position using manual rotation feature.After successful manual rotation and reengaging manual release lever, the bed started functioning normally.The rotoprone device is equipped with two independent systems allowing for the patient surface to rotate, automatic electrical rotation and manual rotation.The buckle alarm will occur if the buckle strap 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 alarm does not prevent the bed from rotating using manual rotation feature, therefore in case a prone dependent patient, which does not tolerate supine positioning, is placed on the bed and alarm condition occurs, the bed can be still turned to prone position.The customer reported that the bed screen showed that the lower prone pack was not tighten enough.Depending on the patient condition, body shape and size the tightness of pack straps will be different to each patient.Due to the gravity, the patient may shift to one side while turning to prone position and for this reason, in order to prevent excessive patient movement, a patient needs to be packed in the device appropriately to the needs: patient shall be positioned in the center of the surface, depending on the body type side support packs shall be placed in a way to accommodate to patient size, pack straps need to be secured by pushing down on packs with one hand and the other hand shall tighten the strap.As per user manual e.G.208662-ah rev.D "tightness of pack straps will vary according to each patient's needs.Straps need to be as tight as can be tolerated, as patient will shift into the prone packs and away from the patient surface when moved into prone position".After end of rental period, the bed was returned to the service center, where was inspected per quality control (qc) check.No failure was found, the asset did not require any repair, which means that there was no bed malfunction, the bed was up to manufacturer's specification.In the course of the investigation, we concluded that there was no bed malfunction, alarm occurred as a result of not sufficient tightening of packs, inappropriate patient positioning on the bed surface or side support packs not placed in accordance to patient needs.We have not been able to find any correlation between an alarm condition and patient loosing saturation.From the complaint description, it can be stated that the saturation was dropping as a result of patient pre-existing condition and due to the fact that was placed in supine position.For patients with low oxygenation reserves, movement to the supine position can result in a significant physiologic decompensation, regardless of the therapy provided by the rotoprone therapy system.The bed could have been manually rotated to prone without any further issues.In summary, the rotoprone device was used for patient treatment at the time of event and thus played a role in the incident.However, it was found that the bed did not fail to meet the manufacturer's specification.The buckle alarm occurred in a result of use error.The buckle alarm did not influence patient condition as it was related rather to the patient placement in supine position then device alarm.We report this incident in abundance of caution since due to limited information provided regarding patient condition 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

Arjohuntleigh received a call from the customer that the patient was placed in supine position, the oxygen saturation was dropping and the nurse was not able to automatically rotate the device due to buckle alarm, which indicated that lower prone pack is not secured.An arjohuntleigh representative who responded to the call, advice to ensure that the sensor was free from obstruction and proning pack was secured.The alarm could not be cleared, patient remained unstable.Staff was instructed to place the device in prone position using manual rotation feature.After successful manual rotation and reengaging manual release lever, the bed started functioning normally.No information regarding oxygen level and the patient outcome was provided.

• 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 ; 98282467
• MDR Report Key: 6521593
• MDR Text Key: 73666310
• Report Number: 3007420694-2017-00088
• 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: 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2017
• 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
• Date Manufacturer Received: 12/14/2016
• 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