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

Model Number 209500

Device Problem Device Alarm System (1012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Despite several attempts to reach the caller and find out more details, there was no return call, no answer from the caller.Message "return patient to zero degree" can occur as part of the several instructions occurring on the bed screen.Without bed evaluation and detailed information what kind of instructions were displaying on the screen at the time of event, it is not possible to indicate the reason for the message and why the staff could not pass this screen.Regardless of the "return patient to zero degree" message, the rotoprone bed can be still rotated to desire position prone or supine using manual rotation feature.In the investigated complaint, users, with help of an arjo representative, were able to manually rotate the patient to supine position and start resuscitation.In summary, when the event occurred the device was used for a patient treatment and from that perspective it played a role in the event.It failed to meet its specification since the message "return patient to zero degree" occurred from unknown reason.We report this event in abundance of caution due to indication of patient coding and no further details about patient outcome.The massage "return patient to zero degree" displaying on the screen is not consider a reportable malfunction.If there is a failure of the electrical system (e.G.The user cannot pass the screen to start automatic rotation), the bed manual rotation feature will override all electrical system and allow to provide the manual rotation, as in the reported case.

Event Description

A call was received from the customer, on 24-hour call line dedicated for rotoprone users, asking for guidance because the nursing were unable to pass the screen displaying information "return patient to zero degree" to get back to the 'home screen' in order to return a patient to zero degree and place the bed in supine position using automatic rotation.Patient was coding.An arjo representative provided instructions to ensure the patient was secured before turning to supine position and instructed the staff on manual rotation.The caller stated they were able to place the bed in supine position and started cpr.No further details, customer name or bed serial number were provided.

• 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 ; ul. ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052
• MDR Report Key: 9149743
• MDR Text Key: 200003923
• Report Number: 9681684-2019-00079
• Device Sequence Number: 1
• Product Code: IKZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 209500
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/04/2019
• Was Device Evaluated by Manufacturer?: No
• 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