MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA CITADEL; BED, AC-POWERED ADJUSTABLE HOSPITAL

Device Problem Human Factors Issue (2948)

Patient Problems Abrasion (1689); Injury (2348)

Event Date 09/05/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The citadel patient therapy system is intended for the acute and post-acute care environments.It is not intended for use in the homecare environment.When used with the citadel bed frame system, the citadel patient therapy system is intended for the prevention and treatment of pressure ulcers, to treat burns and to aid circulation.The addition of skin iq family can aid in the prevention and treatment of skin breakdown and pressure ulcers (stage i-iv) for patients who require microclimate management of the skin.On (b)(6) 2017 arjohuntleigh was notified about the incident with regards to citadel bed by nyph the allen pavilion customer facility.In the received complaint, it was reported that the patient ((b)(6) years old female, weighing (b)(6) ibs) placed on citadel bed sustained stage two linear wound on her thoracic spine.Additionally it was indicated that the patient in question was lying on a natural (not synthetic) sheepskin underpad blocking the skin iq air passages in the system.The sheepskin underpad was placed under the patient from its shoulder to mid- spine.As per certified wound ostomy continence nurse (cwocn) who was interviewed after the reported issue by arjohuntleigh representative stated that the thoracic spine impairment sustained by the resident had a linear appearance what suggests that the injury was caused by friction forces from patient movement on sheepskin underpad.According to cwocn the sheepskin is known to cause friction and heat to the skin, it interferes also with the microclimate of the skin iq mattress cover.It needs to be pointed out that all manufactured citadel beds are checked before being distributed to the customers to verify if the product meets the required manufacturer's specifications and check whether the acceptance criteria are met.Records of the inspection are documented in the device history record (dhr).The device history record has been reviewed for this specific device and no anomaly was found.Following information provided within the complaint record it was established that at the time the incident occurred the device did not fail to meet manufacturer's specification, no bed malfunction was reported by customer.To ensure the safety of our products the instruction for use provided together with the involved device (408204 rev.D) includes the following warning: warning: "monitor skin conditions regularly and consider adjunct or alternative therapies for high acuity patients.Give extra attention to any possible pressure points and locations where moisture or incontinence may occur or collect, early intervention may be essential to preventing skin breakdown".In summary, although no adverse event occurred the complaint was decided to be reportable in abundance of caution due to the allegation of the injury sustained.Upon the conducted investigation, we were able to determine that the sheepskin underpad placed under patient's body was blocking the skin iq air passages in the system what in consequence contributed to the injury occurrence.The device was being used at the time of the event for a patient treatment and due to this played a role in the incident.At the time the event occurred the device was working up to manufacturer's specification.

Event Description

On (b)(6) 2017 arjohuntleigh was notified about the incident with regards to citadel bed.In the received complaint, it was reported that the patient placed on citadel bed sustained stage two linear wound on her thoracic spine that was not there on admission.Additionally it was indicated that the patient in question was lying on a real (not synthetic) sheepskin blocking the skin iq microclimate manager (mcm) which is a fluid resistant, vapor permeable, single patient use mattress cover for use with a pressure redistribution surface to help prevent and treat stage i-iv pressure ulcers.The sheepskin was placed under the patient from its shoulder to mid- spine.The thoracic spine impairment sustained had a linear appearance what suggests that the injury was caused by friction forces from patient movement on sheepskin.

• Brand Name: CITADEL
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA; ul. ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA; ul. ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052
• MDR Report Key: 6907181
• MDR Text Key: 88253894
• Report Number: 3007420694-2017-00201
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Nurse
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/02/2017
• Distributor Facility Aware Date: 09/05/2017
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/02/2017
• Date Manufacturer Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2015
• 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
• Patient Age: 85 YR
• Patient Weight: 45