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

Model Number 209500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Injury (2348)

Event Date 10/08/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Arjohuntleigh received information about an adverse event that occurred at (b)(6) hospital of (b)(6), on (b)(6) 2015.A nurse sustained a serious injury while removing a patient (who desaturated) from the rotoprone bed, which malfunctioned.

Manufacturer Narrative

Please be informed that we (arjohuntleigh) have sent a letter on 25th january 2018 to the customer requesting additional information about the reported event.We are currently looking forward to a response to the letter.Additional information will be provided upon conclusion of the investigation.

Manufacturer Narrative

Arjohuntleigh received a lawsuit alleging that when a plaintiff was employed as a nurse at (b)(6) hospital of (b)(6) on (b)(6) 2015, the rotoprone malfunctioned when a patient, who desaturated, was on the bed, causing the nurse to remove patient from the bed to save the patient's life.In the course of doing so, the nurse suffered physical injuries.The lawsuit stated that the defendant duty was to design and maintain the product in a safe fashion and properly label to prevent the type of injury.No information regarding type of malfunction was provided.Before the incident the nurse went through several accidents and work related injuries to back and shoulders.On 25 january 2018 arjohuntleigh sent letter to the customer requesting additional information.And on 14 february 2018 the customer responded that this incident relates to a lawsuit and declined providing additional information.But indicated that their understanding is that there was no patient injury.Before and after rental period, the quality control (qc) check for involved rotoprone has been performed and no functional issue has been found.Information received from an arjohuntleigh service technician was that the bed had no down time between rents which means that the bed returned from the customer did not require any repair and could have been released to another customer immediately, when ordered.When the bed returned from (b)(6) hospital of (b)(6), was qc check on (b)(6) 2015 and had replaced foams from face pack and tie, beaded 8" secure lock (part number 44722).Please note that face pack foams are changed every 72 hours or as needed.Part no 44722 is attached to the emergency belt release and on the manual move to prone lever access door.It is replaced if damaged or missing.The missing of this part may indicate that manual rotation had been used to put the bed either to prone or supine position.In the investigated case, it is however unknown why the beaded tie part needed replacement.The replacement of face pack foam or beaded tie does not influence bed functionality.Alleged product malfunction could not be confirmed.The rotoprone bed when delivered to the customer has user manual (ifu 208662-ah) attached which includes all relevant information how to operate the bed.Ifu` states "it is recommended that all chapters of this manual be reviewed before operating the unit.Carefully read the contradictions, risk and precautions and safety information sections in the introduction chapter as well as the patient placement chapter of this manual prior to operating the rotoprone therapy system".Additionally, the bed has stickers attached to the foot end of the bed, right side, left side, head pack, head end and bottom of the bed.The stickers provides warnings and indicates how to use e.G.Manual rotation, brakes, hatches.In summary, the nurse was injured when trying to remove patient from the bed, thus in that regards the device played a role in the incident.Due to limited information received, it was impossible to state what was the bed alleged malfunction.After end of rental period it was functional checked and no fault has been detected.Correlation between bed malfunction and serious injury sustained cannot be confirmed.

• Brand Name: ROTOPRONE
• Type of Device: BED, PATIENT ROTATION, POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• MDR Report Key: 7174933
• MDR Text Key: 96733437
• Report Number: 3007420694-2018-00012
• 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: foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Model Number: 209500
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 43 YR