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

Model Number 209500

Device Problem Use of Device Problem (1670)

Patient Problem Bone Fracture(s) (1870)

Event Date 08/22/2020

Event Type  Injury  

Manufacturer Narrative

Please note that previous medwatch reports for this product may have been submitted under the following registration numbers: (b)(4).Currently, this product is to be handled by arjohuntleigh ab's complaint handling establishment and any medwatch reports will be submitted under registration 9681684.The rotoprone therapy system allows an immobile patient to move from the supine to the prone position in an automated fashion.Patients in the bed need to be secured with packs and patient's arms placed in abdominal slings.Before therapy started, patient's proper placement is verified on couple occasions: upon completion of patient placement and before placing the patient to prone position.Product instruction for use (ifu) #208662-ah in section 'pack installation' graphically shows how arms need to be placed in sling.Before placing the bed into prone position, the bed's long checklist screen appears to make sure patient is placed in the rotoprone properly.Ifu states: "ensure patient's arms are secure but not too snug within slings.Once patient's arms are assessed to be adequately positioned and secured, press check arm slings button".When arms are properly placed in the sling, the swing arm is not touching the sling or patient's arm, hence an injury is unlikely to occur.An arjo technical support specialist, who contacted the customer, stated that the patient left hand might have been hanging out of the side of the bed and when the nurses raised a swing arm it jammed the patient's hand.Before the bed was delivered to the customer it was quality control checked.The bed passed the requirement.No repair records were found after the bed in question returned from rent, which would indicate that there was no bed failure.No other complaints with the reported scenario was found either, this event is a singular occurrence.In summary, the rotoprone bed was used for treatment when the reported event occurred and therefore played a role in the event.But the bed did not failed to meet its performance specification.There was no failure which would cause patient harm.This event is deemed reportable due to serious injury sustained by the patient.

Event Description

An arjo sale representative received a text message from a wound care nurse stating that their patient's finger got caught on the side of the bed.Following additional information gathered, a charge nurse stated that the patient broke one of her fingers and maybe fractured her hand.X-ray results were not provided to arjo.According to the charge nurse the nurses were packing a patient into the bed to start rotation to prone.The charge nurse stated that before therapy started nurses made sure the patient had her body and arm positioned in the sling.

• 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 POLSKA SP. Z O.O.; ul. ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer Contact: kinga stolinska ; ul. ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052
• MDR Report Key: 10612514
• MDR Text Key: 209356495
• Report Number: 9681684-2020-00063
• 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: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 209500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2020
• 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