MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP Z O.O CITADEL PATIENT CARE SYSTEM; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number CX811A3F3AMAB0

Device Problem Insufficient Information (3190)

Patient Problem Laceration(s) (1946)

Event Date 06/12/2019

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2019 arjo was informed about the event, which occurred in the (b)(6) hospital in the us.Based on the information reported, the patient was injured while being transfer from the wheelchair to the arjo citadel bed.The patient sustained laceration on the left leg, which required sutures.During visit of arjo representative in the facility, detailed information regarding the event was gathered.The nurse supervisor indicated that she received the report with the event description from the nurse taking care of the involved patient during her night shift.The following points were mentioned in the report: the patient sustained injury during transfer from the wheelchair to the citadel bed; the patient was left in wheelchair unattended outside the room for about 5-10 min.Before the transfer, the caregiver tried to lower the bed but it was not possible; the caregiver checked the bed when the injury was observed, however no sharp edges were noticed.The caregiver stated that the laceration was caused by the bed, however this statement was not supported by any evidence.Arjo representative visited the patient's room to evaluate the bed and the patient confirmed that the laceration was not caused by the citadel bed, however more details were not provided by the patient.It cannot be excluded that the injury occurred before transfer from the wheelchair to the bed, when the patient was left unattended however without first level evidence, it cannot be confirmed.Inspection of the bed showed that the citadel bed and it was at 2degree reverse trendelenburg position, this was the reason why it would not go all the way down.Before the bed is lowered, it needs to be moved to the flat position.The evaluation revealed that there were no failures observed which could contribute to the reported event.Inconsistent information provided by the facility staff and patient did not allow to determine the exact cause of the event and patient's injury.Taking the above into account, it can be concluded that the citadel bed did not fail the manufacturer's specification.No technical malfunction was detected, but the system played a role in the incident as was used during patient treatment.The exact cause of the patient's injury could not be determined based on the gathered information.The reported event is a singular occurrence.The complaint was deemed as reportable due to the serious injury sustained by the patient.

Event Description

On (b)(6) 2019 arjo was informed about the event, which occurred in the (b)(6) hospital in the us.Based on the information reported, the patient was injured while being transfer from the wheelchair to the arjo citadel bed.The patient sustained laceration on the left leg, which required sutures.

• Brand Name: CITADEL PATIENT CARE SYSTEM
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP Z O.O; ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP Z O.O; 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: 8774646
• MDR Text Key: 209391375
• Report Number: 3007420694-2019-00114
• 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 Practitioner
• Type of Report: Initial
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: CX811A3F3AMAB0
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2016
• 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): Hospitalization; Required Intervention