MAUDE Adverse Event Report: KINETIC CONCEPTS, INC ROTOPRONE; BED, PATIENT ROTATION, POWERED

Model Number 209800

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiopulmonary Arrest (1765); Injury (2348)

Event Date 11/07/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A customer reported cpr and lock pin malfunction.It was stated that there was commotion during the time the patient code.The involved bed was checked and no fault was found.The bed was working correctly.

Manufacturer Narrative

The investigation was performed and the conclusions are as follow.The customer reported that cpr and lock pin malfunctioned and that the patient required resuscitation.It is unknown if ¿cpr malfunction¿, reported by the customer, refers to an automatic cpr option or manual rotation options, but based on the description provided by an arjo technician, who was visiting the customer facility and speaking with the nurse, we found that the ¿lock pin malfunction¿ relates to lock pin become stuck in the ¿in¿ position (the lock pin needs to be in the ¿out¿ positon in order for the patient surface to rotate ), after performing manual rotation.This situation can be easily corrected by disengaging emergency release lever and slightly shift the patient surface to release tension on the lock pin.This instruction is clearly described in product instruction for use and labelling attached to the bed foot end.There was no mechanical failure identified with an involved rotoprone bed.An arjo technician pull out the lock pin (following the steps described in the product instruction for use) and the bed was operating correctly.The bed was quality control (qc) checked on november 6, 2019 (pre placement) and again on november 11, 2019 (post placement) and no issues have been detected on both occasions.It is unknown if the bed performance contributed to the patient medical condition.The nurse called to report a malfunction after the patient was taken off the bed, but did not indicate that the bed could have contributed to the patient medical state.The customer stated that there was a chaos during the time the patient code.We reported this event in abundance of caution taking into account information about patient coding, bed malfunction and unknown circumstances of the event.In summary, there was no mechanical failure, but the bed failed to meet its performance specification because of stuck lock pin, the bed was used during patient cpr and in that way played a role in the event, but there is no information suggesting that it could have been directly involved in the patient medical state or delay in cpr.

Manufacturer Narrative

Analysis of the data provided is still ongoing.Additional information will be provided upon conclusion of the investigation.

• Brand Name: ROTOPRONE
• Type of Device: BED, PATIENT ROTATION, POWERED
• Manufacturer (Section D): KINETIC CONCEPTS, INC; 4958 stout drive; san antonio TX 78219
• MDR Report Key: 9422541
• MDR Text Key: 185749333
• Report Number: 9681684-2019-00096
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2020

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
• Device Model Number: 209800
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/07/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 11/07/2019; 11/07/2019
• Supplement Dates FDA Received: 01/02/2020; 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening