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

Model Number 209800

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Scar Tissue (2060)

Event Date 07/30/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).A supplemental report will be submitted once investigation conclusions are available.

Event Description

Arjo received a medwatch report #mw5098349 from a patient, who stated that after taking a medications containing hydrocodone she was placed on rotoprone bed.The patient stated she received scars on her face allegedly from being incorrectly placed on the bed.

Manufacturer Narrative

The fda forwarded to arjo a voluntary event report (mw5098349) submitted by a patient, who was placed on a rotoprone, around july 30, 2017 (date of event indicated in the report), for the treatment after taking a life-threatening combination of drugs.The patient report refers, mainly, the their concern about the health consequences they suffered after taking the medications.It also includes, a patient statement referring to arjo rotoprone bed, alleging, that they sustained scars on their face from being incorrectly placed on a bed.This report refers to the statement related to rotoprone bed.In the report, a patient did not indicate the hospital name and address in which the patient received the treatment.Nevertheless, arjo in attempts to identify the serial number of the bed searched through the history of rents in usa and the calls from that time period.Arjo found a call from harborview medical center located in seattle, related to the rotoprone with serial number (b)(6).We checked the quality check control for this bed, performed on (b)(6) 2017 (after end of rental period) and did not find any discrepancies, the bed was operating correctly.The rotoprone bed has various options to adjust the surface for patient physique.The head support has several knobs that can be used to adjust face pack to patient's face depending on the needs.The rotoprone instructions for use (ifu) 208662-ah states: ¿it is very important that the patient¿s ears remain aligned with the openings in the head support.Proper positioning and alignment of the head and ears determines optimum support for the patient¿s head.Check head position often during the remainder of the patient placement procedure, especially when all other packs are positioned and tightened.¿ ¿turn head support adjustment knob to close head support around patient¿s head.Head support packs should lightly touch sides of patient¿s head without compressing the pack foam or puckering patient¿s skin.¿ the patient submitted the report 3,5 years after the event.It is unknown why the patient had scars on her face.The allegation of being incorrectly placed on the bed, cannot be verified.Arjo device was used for a patient treatment when the event occurred and from that perspective it played a role in the event.There are no indications that the device was not operating correctly, the subsequent quality control (after the end of rental period) did not reveal any malfunctions.We report this event, solely, due to serious injury sustained by a patient while using rotoprone.

• 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: 11366051
• MDR Text Key: 233087095
• Report Number: 9681684-2021-00007
• 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: other
• Type of Report: Initial,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• 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
• Date Manufacturer Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization