MAUDE Adverse Event Report: ARJOHUNTLEIGH ROTOPRONE

Model Number 209500

Device Problems Use of Device Problem (1670); Unintended Movement (3026); Insufficient Information (3190)

Patient Problems Contusion (1787); Fall (1848)

Event Date 05/25/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient was placed on the device on (b)(6) 2015 around 2:00 am.The arjohuntleigh service consultant was present during the patient placement and stayed for 30-40 minutes to observe the bed operation (prone and rotation) nothing amiss has been noticed.Event occurred day after the patient placement, on (b)(6) around 8:15 pm the patient fell out of the rotoprone device.In accordance to information provided by the facility: two facility members were assessing the patient together and giving bedside report; facility members were preparing to buckle and secure the patient into the bed; firstly check of the bed was conducted to make sure that the lock pin at the end of bed was pushed in securely and that the bed would not move; then the facility staff began to assess the patient's legs, skin and reposition 'foley' catheter for resident's comfort.Chest velcro strap was checked and secured.The facility member started to secure the patient from the feet end.One person was on the patient's left side while bringing the buckle up, she felt that the bed jolt a little.She thought that the person from the other side of the be was having some trouble.She went over to help and asked if the second person was having trouble, she said no.As she started to lift her side up the bed turned to the left.The patient fell to floor.Prone position.The bed stayed in the left position.Before the facility staff started to buckle patient in, after assessing legs and reposition the 'foley', the lock pin was checked a second lime to ensure bed would not move.Pin was observed to be in.Both times it was checked.As a result of the fall patient suffered contusion - exact outcome is currently unknown.Additionally, during the fall the pic line were being pulled out.Patient has a ct scan and has been hospitalized.Additionally, we manage to clarify that the patient involved in the event was 32 years old female with weight (b)(6) (approx.(b)(6)).In accordance to the device labeling (user manual #208622-ah rev.C) which was delivered to the facility together with the device and information provided by the facility revealed that the maximum recommended patient weight is (b)(6).After the event the device has been quarantined and is wailing for the inspection.

Manufacturer Narrative

(b)(4).When reviewing similar reportable events for the rotoprone devices, we have not been able to find any other event with the fault descriptions compared to the situation investigated here: patient fell out of the device.There is no trend observed for reportable complaints with this failure for these devices.Based on the information collected to date, provided problem description and evaluation of the device involved in the event, we have been able to establish that normally the patient-supporting surface could freely rotate, only if the lock pin has been 'in the middle' or 'out' position and the emergency release lever has been released.The lock pin mechanically locks the patient surface into place.At 0 degree, supine position, thanks to which the surface cannot move as long as the lock pin is engaged.The lock pin has 3 positions, 'in', 'out' and 'in the middle'.When the lock pin is fully engaged ('in' position), it does not allow the patient surface to rotate.When it is in fully 'out' position, it allows the operation of rotoprone.The 'in the middle' position is when the lock pin can be pushed in and rotation is stopped but the patient surface is not locked.It is possible only if the lock pin is pushed when the bed is not in the zero, supine position.If the lock pin is not engaged, the patient surface is still not able to rotate freely.The belt that turns the patient's surface holds the tension, not allowing the patient's surface to rotate.The only way it can freely rotate, is when the lock pin is not engaged and the emergency release handle is released.The emergency release is located on the foot end of the rotoprone and is used to manually rotate the patient surface.This lever is secured with a beaded tie.When the emergency release is pulled, the beaded tie is broken.The device involved in the event was inspected between 28 and 30 september 2015, by an arjohuntleigh representative who clarified the following: the beaded tie was not present on the emergency release lever.This indicates that the manual rotation was utilized at some point during the rental period.In order to verify the correct operation of the lock pin, a test with load was conducted (380 lb water dummy was used in order to reproduce the patient's weight).The lock pin was engaged and the load of over 200 lb was put on the left side of the patient surface (in this direction the unexpected rotation, claimed by the customer, occurred).There was no movement of the patient's surface.The lock pin was pulled out and the force of over 200lb was applied.No surface movement was observed either.The patient surface rotated only if it was commanded by the user interface or hand control.It was observed that once the lock pin is in 'out' or 'in the middle' position and the emergency release lever is released, it takes only 15 lb of force to rotate the patient surface.Once the patient's weight shifts towards one side, the surface can easily rotate to prone position.The following four issues were identified with the device during the inspection, however found not to be related to the issue at hand (we share them here to be transparent and complete in our communication): the cpr button on the foot end was inoperable (the middle pin on the cpr's cable connector has been partially pushed out, which could cause the intermittent operation when the cpr button was pressed); the bed was not spinning freely when the emergency manual belt was disengaged (the drive belt was too tight are needed adjustment); the side support crank operates correctly but it was slightly bent; one of four solenoid ring bolts was not fully tightened.As indicated these issues do not seem to be relevant to the investigated event.Review of the device labeling (user manual #208622-ah rev.C) which was delivered to the facility together with the device and information provided by the facility revealed that in accordance to the device labeling one of the contraindication with use of the device is patient weight above 350 lb /159 kg.In this investigated event, the safe working load of the device was exceeded, the patient weight was (b)(6).In summary, the device was being used at the time of the event, it failed to operate as intended as it did not suffer a malfunction but stopped performing as intended - likely due to a use error, and in doing so it contributed to the outcome of the event - patient fell out of the bed.Given the circumstances and the number of similar events, this incident appears to be an isolated one.We shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

After further clarification it has been established that the day of delivering the device to the customer was 25th of may, not as initially indicated 24th.

• Brand Name: ROTOPRONE
• Manufacturer (Section D): ARJOHUNTLEIGH ; san antonio TX 78219
• Manufacturer (Section G): ARJOHUNTLEIGH, INC. ; 4958 stout dr.; san antonio TX 78219
• Manufacturer Contact: pamela wright ; 12625 wetmore. ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 4861422
• MDR Text Key: 162443080
• Report Number: 3007420694-2015-00120
• 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: health professional,user faci
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 10/28/2015,05/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2015
• 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?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/28/2015
• Distributor Facility Aware Date: 05/25/2015
• Date Report to Manufacturer: 10/28/2015
• Date Manufacturer Received: 10/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization
• Patient Age: 32 YR
• Patient Weight: 173