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

Device Problems Human Factors Issue (2948); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191); Device Handling Problem (3265)

Patient Problem Tissue Damage (2104)

Event Date 01/09/2017

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 #(b)(4)).From (b)(6) 2012 until 2014 complaints related to this product were handled by arjohuntleigh inc, and any medwatch reports were submitted under registration (b)(4).From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh ab's complaint handling establishment and any medwatch reports will be submitted under registration (b)(4).Additional information will be provided upon conclusion of the investigation.

Event Description

Arjohuntleigh was informed that an unstageable pressure ulcers on right and left cheek bone of patient face was discovered.Patient was placed on the rotoprone on (b)(6) 2017 for 16 hour prone therapy sessions.Over the weekend the nurse discovered wounds on the patient's cheekbones under the facepack device.

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 (b)(4).From november 2012 until 2014 complaints related to this product were handled by arjohuntleigh inc, and any medwatch reports were submitted under (b)(4).From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh (b)(4) complaint handling establishment and any medwatch reports will be submitted under (b)(4).An investigation was performed into the issue and conclusions are following: the allegation was that the patient was placed in prone therapy session for 16 hours starting from (b)(6) 2017.On (b)(6) 2017, unstageable pressure ulcers were noticed on patient's both cheeks.The device involved in the incident is the rotoprone bed, which is a part of the arjohuntleigh us rental fleet and had been rented to customer: (b)(6).After the unit was returned from rental, it was tested per quality control procedures post placement: the outcome is the same as that of the pre placement qc: on both occasions, the bed passed quality control (qc) checks, functioned as designed and met specifications.No anomalous conditions were found on the bed and facemask during pre and post inspection.When reviewing similar reportable events, we were able to establish that there have been similar complaints in the past, which cover problem with patient sustaining injuries in the area of face/head pack/ face mask.There is no complaint trend observed for this failure mode and occurrence is considered to be remote.The device's user manual states that the head support, face pack and other proning accessories shall not be fitted too tightly as this may increase pressure point and result in serious skin breakdown.Patient skin is to be assessed at frequent intervals depending on patient condition (at least once every four hours).Face pack shall be removed regularly to assess the facial skin.It is recommended to not leave patient in a stationary position in the supine or prone position for more than two hours.User manual provides, also, guidance of how to place and adjust face pack assembly, it states: "assess position of cheek packs on patient's cheeks and chin.[.] face pack should rest lightly on patient's forehead, cheeks and chin with no compression of the foam".When the therapy starts, the user manual instructs to re-examine patient's placement in head support assembly, ensure that there is no pressure on or around the eye and check the patient position regularly during the therapy.No issue with the involved unit was found during cleaning and quality control check, moreover the customer itself expressed the need for additional training regarding placement and adjustment of the face pack assembly.Therefore, based on the information gathered, we find it most likely the user techniques - which appear out of line with the user manual - during patient placement as a root cause of the issue.The rotoprone device was used for patient treatment at the time of event occurrence and thus played a role in the incident.However after the comprehensive evaluation it was found that the bed did not fail to meet the manufacturer's specification.The patient did sustain a serious injury, thus the event was decided to be reportable to competent authorities as such type.

• 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 ; ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052 ; 98282467
• MDR Report Key: 6310199
• MDR Text Key: 66763399
• Report Number: 3007420694-2017-00026
• 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
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/20/2017

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2017
• Initial Date FDA Received: 02/08/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/20/2017
• 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