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

Model Number 209500

Device Problem Difficult to Open or Close (2921)

Patient Problem Death (1802)

Event Date 01/31/2018

Event Type  Death  

Manufacturer Narrative

Please note that this product is no longer manufactured and previous medwatch reports for this product may have been submitted for the manufacturing site kinetic concept inc (under registration #1625774).From november 2012 until 2014 complaints related to this product were handled by arjohuntleigh inc, and any medwatch reports were submitted under registration #3009988881.From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh (b)(4)'s complaint handling establishment and any medwatch reports will be submitted under registration #307420694.Additional information will be provided upon conclusion of the investigation.

Event Description

Arjohuntleigh representative (a linc line operator) received a call from the customer stating that they could not open pelvic prone pack on the patient in a supine position following an unsuccessful code attempt.The allegation was that the buckle could not be opened during the code and that the accessing the patient interfered with the code.

Manufacturer Narrative

On (b)(6) 2018, arjo representative ((b)(6) operator) received a call from the customer (b)(6) hospital located in (b)(6) regarding inability to open pelvic buckle during active cpr.The nurse stated that accessing the patient (male, weight (b)(6)lbs) was difficult because the prone pack could not be unbuckled despite several people trying to push on the pack to loosen it and it interfered with the code blue.An arjo service center team leader stated that when the service technician went to the facility to help release the buckle, the patient was still in the bed and the patient had expired.The patient was large in size, both tall and heavy (described by the technician as having a large midsection).Buckles are used to restrain a patient on the rotoprone when the patient is in supine and prone therapy.The buckle assembly functions much like a seat belt buckle with webbing connected on the right and left side of the bed and a tongue and buckle that get latched in the center of the bed to restrain the patient.The operator of the device clicks the male and female component of the buckle together and tightens the pack straps.The buckle is released by pressing the red button inside the buckle.Bed evaluation performed on (b)(6) 2018, revealed that there was no buckle failure, the involved part was engaged and disengaged several times without issues.One part was found faulty - the axilla adjustment mechanism did not lock.This however had no impact on the buckle release mechanism.The issue reported by the customer was recreated.An accessory bag was placed on the patient surface, the straps from proning packs were pulled very tightly.When attempting to open the buckle it was noticed that the red button was difficult to push to unbuckle the buckle.To open the buckle, a force was applied on the proning pack pushing it down to reduce the tension built in the buckle release mechanism.The customer allegation has been confirmed.Two possible causes have been identified: proning pack strap was pulled too tightly or the patient could have become swollen from iv therapy causing the straps to get tighter.Please note also, that the rotoprone bed was quality control (qc) checked before the delivery to the customer on (b)(6) 2018 and passed the manufacturer's requirements.User manual (#208662-ah rev.D), which is provided with each device, contains all crucial warnings, cautions and instruction which should be followed to ensure the patient safety.In the document following information can be found: the instruction how to secure pack straps during patient placement, "first push downward on pack with one hand, then tighten the strap with the other hand" "tightness of pack straps will vary according to each patient's needs.Straps need to be as tight as can be tolerated", "do not place pelvic proning packs over the upper abdomen.Placement of the pelvic packs should allow for abdominal expansion during therapy" "ensure all proning pack buckles are securely fastened and straps adequately tightened".In summary, the arjohuntleigh device played a role in the event as it was used for the patient treatment.The device failed to meet its performance specification because of inability to open the buckle during active cpr.We are reporting this event to the competent authority because of the patient's death.

• 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, P ; PL 62-052, PL
• MDR Report Key: 7250793
• MDR Text Key: 99322383
• Report Number: 3007420694-2018-00039
• 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: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/20/2018

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: Nurse
• Device Model Number: 209500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/31/2018
• Initial Date FDA Received: 02/08/2018
• Supplement Dates Manufacturer Received: 02/26/2018
• Supplement Dates FDA Received: 03/20/2018
• 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): Death
• Patient Weight: 131