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

Model Number CX811A3F3AMAB0

Device Problems Human Factors Issue (2948); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 10/19/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

In the complaint at hand it was reported that patient slide off of the bed to the floor and during that process hit the bed and received a right eye laceration.

Manufacturer Narrative

This report is being filed under exemption e2012070 by (b)(4).On (b)(6) 2017 arjohuntleigh was notified about an customer complaint involving citadel bed.The reported malfunction took place in the multicare auburn regional medical center in the united states.Following the information reported the patient slide down to the floor while attempting to get out of bed.During that activity the patient hit the bed and in consequences sustained right eye laceration.To close the wound steri-strips were used (no sutures).It needs to be emphasized 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.The bed in question was a rental asset, not the customer owned.The last preventive maintenance was performed in 2017-feb-14.There were no previous repairs on that bed.After the event occurrence the bed was inspected by arjohuntleigh technician in regards to the alleged incident.The evaluation revealed that there was no technical deficiency found within the device that would have adversely affected this incident.All bed functions were tested and all operated as intended.According to opinion presented by the customer facility representative, the patient involved in the event was not in a condition to get himself out of the bed but he was able to scoot toward the foot of the bed, attempting to get himself out.Moreover it needs to be emphasized that at the time the incident occurred, the side rails (intended to support the patient from falling down from the device) were left in down position and the exit alarm (intended to alert when undesired movement of the patient occurs) was not activated.To ensure the safety of our products the instruction for use provided together with the involved device (830.213 rev.D dated nov 2015) includes the following information and warnings: warning : "the clinically-qualified person responsible should consider the age, size and condition of the patient before allowing the use of side rails".Information: "side rails are not intended to restrain patients who make a deliberate attempt to exit the bed." warning: " to minimize risk of falls or injury, the bed should always be in the lowest practical position when the patient is unattended." warning: " caregiver should always aid patient in exiting the bed.Make sure the capable patient knows how to get out of bed safely (.) ".Information: "the patient movement detection system can be set to alarm when undesired movement of the patient occurs." in this particular case the patient was not supported while exiting the bed and the device was not lowered to the lowest practical position while being unattended.Moreover the side rails were left in down position and no exit alarm was activated.Based on the above we can conclude that the user not following the recommendations in product instructions for use contributed to the incident the complaint was decided to be reportable due to the allegation of patient's fall and the injury sustained (eye laceration).The device was being used for patient care at the time of the incident.Upon the conducted investigation and bed inspection done by the arjohuntleigh representative, we were able to determine that user not following ifu influenced on that incident.There was no technical deficiency found within the device.At the time the incident occurred the citadel bed met its manufacturer specification.

• Brand Name: CITADEL PLUS
• 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: 6987008
• MDR Text Key: 91932924
• Report Number: 3007420694-2017-00214
• 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: user facility
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CX811A3F3AMAB0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/29/2017
• Distributor Facility Aware Date: 10/20/2017
• Device Age: 2 YR
• Event Location: Other
• Date Report to Manufacturer: 11/29/2017
• Initial Date Manufacturer Received: 10/20/2017
• Initial Date FDA Received: 10/30/2017
• Supplement Dates Manufacturer Received: 11/22/2017
• Supplement Dates FDA Received: 11/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2015
• 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