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

Model Number FX811B3B4AMABB

Device Problem Use of Device Problem (1670)

Patient Problems Fall (1848); Blood Loss (2597)

Event Date 11/16/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported to an arjo service consultant by a customer representative that a patient fell out of an arjo citadel plus bed, and was hit in the head.He was bleeding, therefore, a computed axial tomography (cat) scan was done and the patient was monitored.There was no indication that any other medical intervention was needed.An investigation was conducted to establish a root cause of the reported issue.It was clarified that the reported fall occurred because a bed side rail unexpectedly released under force exerted by the patient who wanted to lift himself up holding them.According to the customer representative, the bed side rail was not completely locked as a mattress placed on the bed (arjo maxxair ets mattress) was stuck in between the side rail at the time of the incident.Following the event, the involved bed was inspected by the arjo representative.The evaluation revealed that all side rails worked properly.The facility staff was informed how to lock the side rail correctly.According to the instruction for use (831.374), arjo recommends to ¿verify side rails are raised and locked¿ at time of patient¿s transfer.There is also warning to ¿make sure the locking mechanism is securely engaged when the side rails are raised.¿ the arjo bed was being used for transport of the patient at the time of the event.No technical problem was identified within the side rail mechanism.Although no serious injury was reported, the complaint decided to be reportable due to the patient¿s fall.

Event Description

It was reported to an arjo service consultant by a customer representative that a patient fell out of an arjo citadel plus bed and hit in the head.He was bleeding therefore, a computed axial tomography (cat) scan was done, and the patient was monitored.There was no indication that any other medical intervention was needed.

• Brand Name: CITADEL PLUS
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 688282467
• MDR Report Key: 10913436
• MDR Text Key: 218576057
• Report Number: 3007420694-2020-00178
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05055982756532
• UDI-Public: (01)05055982756532(11)170807
• 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: Other
• Type of Report: Initial
• Report Date: 11/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: FX811B3B4AMABB
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2017
• 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 Weight: 272