MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. ROTOPRONE; IKZ

Device Problems Loose or Intermittent Connection (1371); Device Handling Problem (3265)

Patient Problem Death (1802)

Event Date 09/26/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).On (b)(4) 2016 arjohuntleigh was informed about the incident that took place at (b)(6) hospital while using rotoprone bed, serial number (b)(4).As from the fda medwatch report # 0504850000-2016-8010 submitted by the customer, arjohuntleigh has learnt that: a patient was placed from prone to supine position to assess patient's skin/ett/cvp/arterial lines.After 5 minutes the patient experienced desaturation and the nursing staff attempted to placed back the bed surface in prone position with use of automatic rotation.In the process of going from supine to prone position the bed started alarming.The massage on the screen suggested that the chest buckles were loose.It was stated that the alarm condition prevented from placing the patient into the prone position.Eventually, the patient passed away on (b)(6) 2016.If the buckle is open or not tight enough, an alarm will occur during rotation.This alarm is to protect the patient from falling out of the bed during rotation.The bed surface can be still manually rotated, the alarm would not prevent the patient surface from returning to prone.As per user manual 20862-ah rev.D section 'alarm and troubleshooting' in order to correct the buckle alarm condition, if the patient can tolerate, the surface needs to be returned to 0 degree supine using the cpr button on the frame.Based on the information gathered, thus far, we concluded that: the customer made one linc call (a 24h phone number dedicated to rotoprone users) on (b)(4) regarding the issue with "adjusted weight".There are no other records of linc calls for anything related to this particular event, the customer received 2 corporate training sessions within the last year on (b)(4) 2015.Additionally day/night shift training was performed on (b)(4) 2016.The nursing staff did not use the manual rotation to place the patient in prone position.It was noticed, after the bed had been quarantined, that the yellow beaded ties (which indicate the possibility of using manual rotation) remained intact.Please note that on october 4, 2016 arjohuntleigh received communication from fda regarding report number 0504850000-2016-8010 where we have been requested to provide additional information.According to the request in the letter and given date due, the response to the questions and the follow-up report with additional information will be sent to the authority till november 18, 2016.

Event Description

On (b)(6) 2016 arjohuntleigh was informed about the incident that took place at (b)(6) hospital on rotoprone bed, serial number (b)(4).The patient died on (b)(6) 2016.The device was used by a facility from (b)(6) 2016.Per facility medwatch report: "other devices in use on patient: patient in a prone therapy bed, was in prone position at 15 degrees.With aide of 2 rns placed patient to supine position with the goal to assess the skin/ett/cvp/arterial lines.Patient being monitoring closely for signs of decompensation.After 5 minutes noticed desaturations, so quickly with the aide of the 2 other rns placed cushions back onto patient and attempted to place back into prone position.The bed kept alarming that the chest buckles/straps were loose and would not let us complete prone position.Attempted however the at least 3 times to fix the chest buckles/straps alarm kept ringing.At this time noticed that the patient started to desat and hr dropped to 40's.A chemical code was called.Patient became asystole/pea.Medication resuscitation became futile and with family attempts were called off.".

Manufacturer Narrative

(b)(4).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.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, but only two within the last 5 years carry a similar scenario where an buckle open alarm occurred and in an emergency situation manual rotation was not used.The occurrence of complaints (non reportable and reportable) with the allegation of buckle open alarm is irregular and decreasing.The product involved in the incident is a rotoprone bed serial number: (b)(4), manufactured in june 2004.The device is part of the arjohuntleigh us rental fleet and has been rented to the customer long beach memorial hospital from september 20,2016 to september 26,2016.Upon the conducted investigation, we were able to confirm that this device passed the quality control checklist on september 20, 2016, before being placed at the customer site.Customer stated that in the process of placing the bed from supine to prone position, the bed started alarming with chest buckle being loose preventing further automatic rotation.Despite of 3 times attempts to tighten the straps, bed kept alarming.At that time it was noticed that the patient started to desaturate and heart rate dropped to the 40's, a chemical code was called.Patient became asystole/pea.Medication resuscitation became futile.If the buckle is not buckled or not tight enough, a buckle open alarm will occur during rotation.This alarm is to protect the patient from falling out of the bed or migrating during rotation.The buckle alarm will occur when the striker plate on the proning arms are not in contact with a tape switch on the side of the patient surface.There is a tape switch on the left side and one on the right side of the proning pack.Both tape switches need to be engaged to avoid a buckle alarm.If either one or both tape switches are not engaged, a buckle alarm will sound during rotation.The tape switch detects two pieces of information for the rotoprone: the first piece of information is that the buckle must be fastened; the second piece of information is that the proning arm strap to be tight.The proning arm strap must be tight enough to hold the proning pack close to the patient surface.The rotoprone has built in mitigations for turning the patient surface during a buckle alarm.Either the emergency release handle could be used to prone the patient or the cpr on the foot end plastic cover or user interface could be used to return the patient to supine in order to tighten the chest strap.The bed was quarantined after the event and evaluated in los angeles, ca service center.The bed evaluation did not reveal any anomalies or malfunction, bed was working according to specification.Visual inspection has not revealed any defects or damages, the tape switches and striker plates were checked and no damage was noted either.Both cpr button on the foot end plastic cover and emergency release handle function was verified.No failure was found.The bed could have been place in supine in order to tighten the straps and in prone position with use of the manual features.No defect within the manual rotation features was observed.It was noticed that beaded ties were present on the emergency release handle and on the door to access manual rotation lever.When the emergency release handle and door are pulled, the beaded ties will break.With the device related to the event these ties were in place, which means that the manual rotation feature was not utilized.The event as described by the facility was recreated.The chest buckle was left loose, the rotation was initiated to prone position, the buckle alarm occurred as per design.When bed was at about 20 degree, the chest strap was unable to be tightened enough to stop the alarm.Bed was returned back to supine with use of cpr button on the foot end plastic cover.Once the bed was placed in supine position, the recreations showed that the strap could have been tightened, alarm corrected and patient could have been placed in prone.The situation was repeated with use of emergency release handle and the patient surface was placed in prone position with success.Please note, that there are three ways to return the patient surface to supine position during a buckle alarm: by pressing the cpr button on the user interface, by pressing the cpr button on the foot end plastic cover of the bed, by releasing the emergency release handle and manually rotating the patient surface to supine position, in order to manually rotate the patient to prone position, the emergency release handle needs to be released and manual rotation lever needs to be lifted and held for appropriate duration of rotation.Provided with each patient placement is a user manual, part number 208662-ah revision d.The user manual contains specific instructions on how to use the powered cpr function and the emergency release.The emergency release feature disarms all safety alarms.In the scenario described by the facility, neither one of these functions were employed to rotate the patient to the desired position, neither supine nor prone.The emergency release handle and cpr button are clearly marked and all labels were present.Also in section 'safety information' of the rotoprone's user manual the following statement can be found: "cpr and manual rotation features - caregivers and other hospital personnel are required to become familiar with the cpr function and the emergency release procedures for automatically or manually rotating the patient surface, as well as the other procedures required to access the patient in case of an emergency".Once an alarm is triggered, the customer is advised to follow the instructions on the screen.There were no malfunctions nor service issues that contributed to this incident based on an evaluation of the device and a review of complaint records.In arjohuntleigh's investigation it was determined that the most likely root cause of this event was user error.In summary, the device was being used at the time of the event and it appeared to fail to operate as intended, however after the comprehensive evaluation it was found that it did not suffer a malfunction but stopped performing due to a use error.In this way the device contributed to the outcome of the event - patient death.The incident was reported due to the patient outcome and not the bed malfunction.Given the circumstances and the fact that the issue was, most likely, related to the use error, arjohuntleigh intends to remind the customer how to utilize cpr functions, including manual rotation features.Arjohuntleigh shall continue to monitor for any further events of this nature.

• Brand Name: ROTOPRONE
• Type of Device: IKZ
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. wawrzyniaka 2; komorniki, 62-05 2, P; PL 62-052, PL
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. wawrzyniaka 2; komorniki, 62-05 2, P; PL 62-052, PL
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 6043295
• MDR Text Key: 57968415
• Report Number: 3007420694-2016-00220
• 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,health
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 10/20/2016,09/27/2016

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: Nurse
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/20/2016
• Distributor Facility Aware Date: 09/27/2016
• Event Location: Hospital
• Date Report to Manufacturer: 10/20/2016
• Initial Date Manufacturer Received: 09/27/2016
• Initial Date FDA Received: 10/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/18/2016
• 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): Death
• Patient Age: 58 YR