MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. ROTOPRONE; IKZ

Device Problem Use of Device Problem (1670)

Patient Problem Pressure Sores (2326)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Arjohuntleigh has been informed that the patient, who was using the rotoprone device, sustained a tissue injury during proning.From information provided is appears that patient developed 8 pressure ulcers all between stage ii and iv: one on the left cheek, one on the right cheek, 4 on the abdomen and one on each thigh.

Manufacturer Narrative

(b)(4).Please note that following has been corrected: previous type of reportable event: malfunction.Correct type of reportable event: serious injury.Arjohuntleigh has performed an in depth investigation into the issue and concluded following: the product involved in the incident is a rotoprone bed, serial number: (b)(4).The device is part of the arjohuntleigh us rental fleet and has been rented for customer (b)(6) hospital.Each device needs to pass the quality inspection (conduced in accordance to approved work instruction) before being released to the customer for rental period.Device must be in full working condition in order to pass the test and be cleared for dispatch.With the complaint at hand, we have been informed that during usage of the rotoprone designed functions, the patient developed several pressure ulcers.The arjohuntleigh representative tried to immediately contact the customer in order to gather more information, however the facility stated that "everything was under control".The initial contact was ended with telephone assistance regarding proper patient placement techniques, the device remained at the facility.During a second attempt in assisting the customer it has been concluded that: the icu staff was not removing the mask and relieving pressure from the buckles when the patient was in the supine position.The device was not being rotated regularly, leaving the patient in one position for a long period of time the nurse stated the patient was moving around a lot in the bed and was not packed properly.The user manual (#208662-ah rev.C) is being delivered with each device and provides all necessary information regarding proper patient placement and skin care routine.It is recommended that all chapters of the manual be reviewed before operating the unit.Within this document, the user is informed that fitting the head support, face pack or other packs too tightly may increase pressure points, possibly leading to skin breakdown.Assess skin at frequent intervals depending on patient condition (at least every 4 hours).Give extra attention to skin at pressure points and locations where moisture or incontinence may occur or collect.Common pressure points include, but are not limited to, the face, ears, axilla, shoulders, sides and upper and lower extremities.Early intervention may be critical to preventing serious skin breakdown.The patient should not be left in a stationary position in the supine or prone position for more than two hours.Also, during the rotational therapy the caregiver should observe patient for movement or shift within packs.Additionally, hatches should be used when the patient surface is in the prone position to access posterior of patient for bathing, skin check tube / line check and other patient care needs.It also appeared that although the facility has a very thorough placement and use protocol that was developed years ago and it has undergone updates, it seems most likely that they were not following their own protocols at this point.During the investigation course, it has been established that at the beginning of the year the training has been offered routinely, but the account has not accepted.With this incident the company's critical care education team was given the contact information for the facility managers and offer an additional training to prevent this situation from reoccurring.Based on the information gathered, we deemed the user technique to be a root cause of the problem, regardless the fact that the facility appears to have a good protocol in place and was provided with user manual upon the device delivery.Arjohuntleigh device has played a role in the event, as it was used for the patient treatment.The injuries sustained were classified as a serious injuries, thus the event was decided to be reportable to competent authorities as such type.Given the circumstances and the fact, that there is no trend observed for similar adverse events, arjohuntleigh does not propose any other action at this time.

• Brand Name: ROTOPRONE
• Type of Device: IKZ
• 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: pamela wright ; 12625 wetmore; ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 5597304
• MDR Text Key: 43513659
• Report Number: 3007420694-2016-00078
• 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
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 06/07/2016,03/24/2016

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: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/07/2016
• Distributor Facility Aware Date: 03/24/2016
• Event Location: Hospital
• Date Report to Manufacturer: 04/22/2016
• Initial Date Manufacturer Received: 03/24/2016
• Initial Date FDA Received: 04/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/07/2016
• 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): Other