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

Model Number FXX21C4B1AAABB

Device Problem No Apparent Adverse Event (3189)

Patient Problems Head Injury (1879); Injury (2348)

Event Date 03/31/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4) on 12 apr 2017 arjohuntleigh has received a customer complaint involving citadel plus bed (serial number: (b)(4)) and joems oxford presence 227 hoist (non-arjohuntleigh device).The reported malfunction took place in the (b)(6) hospital in (b)(6).It needs to emphasize that this event was decided to reportable to the competent authorities due to arjohuntleigh device taking part in the event which would be likely to cause or contribute to a death or serious injury upon recurrence, although arjohuntleigh device was not being the cause of the incident.Following the information reported, while three staff members (one qualified and two healthcare support workers) were attempting to lower the patient being hoisted on joems oxford presence 227 device which is non-arjohuntleigh product onto citadel plus bed, the hoist suddenly tilted.The staff member was trying to support the patient to ensure patient's safety.While doing so, it was reported to us that one staff member was hit in the head by the hoist and other staff member sustained some foot injury.Nurse advised them to visit emergency department, however the staff members declined as injuries were not lasting.No further details were disclosed.In staff members' opinion the hoist tilted due to power drive box (in which 5th castor is placed) located underneath the bed as this prevented them to position the hoist correctly in order to lower the patient safely.The nurse was unable to confirm neither the brakes of the hoist were in operation while the incident occurred nor the hoist's legs were splayed.She confirmed that to her knowledge the correct sling have been used for patient's weight.After the incident, the device was moved through the arjohuntleigh inspection where no fault was found within the hoist.Last service record of the hoist was dated on 12 sep 2016.Arjohuntleigh representative was not in position to inspect the bed involved in the incident as the device had not been made available.Technician check other device of the same type at the facility to verify customer allegation.The technician noticed that the only place for lift to stumble was the most likely power drive box located under the bed, however as there was no product failure found it can be assumed that the issue was related to the caregivers inadvertency what further resulted in lift tilting.Looking at the sequence of events reported, this particular complaint is considered to be a single, isolated event, no complaints were found concerning the same or similar event in arjohuntleigh complaint handling system.Upon the course of the investigation we were able to confirm that arjohuntleigh device was found not to have malfunctioned (was performing up to the specification) when the event took place.Arjohuntleigh device was not being the cause of the incident.When the resident was being positioned into arjohuntleigh bed, using non arjohuntleigh device - the floor lift tilted sideways and injured the caregivers.Arjohuntleigh device was not used for a patient therapy and care.It has been deemed unlikely that the arjohuntleigh bed could have contributed to the caregiver's outcome in any way.Device unavailable for inspection.

Event Description

On 12 apr 2017 arjohuntleigh has received a customer complaint involving citadel plus bed (serial number: (b)(4)) and joems oxford presence 227 hoist (non-arjohuntleigh device).The reported malfunction took place in the (b)(6) hospital in (b)(6).It needs to emphasize that this event was decided to reportable to the competent authorities due to arjohuntleigh device taking part in the event which would be likely to cause or contribute to a death or serious injury upon recurrence, although arjohuntleigh device was not being the cause of the incident.Following the information reported, while three staff members (one qualified and two healthcare support workers) were attempting to lower the patient being hoisted on joems oxford presence 227 device which is non-arjohuntleigh product onto citadel plus bed, the hoist suddenly tilted.The staff member was trying to support the patient to ensure patient's safety.While doing so, it was reported to us that one staff member was hit in the head by the hoist and other staff member sustained some foot injury.Nurse advised them to visit emergency department, however the staff members declined as injuries were not lasting.No further details were disclosed.

• Brand Name: CITADEL PLUS
• 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 ; 98282467
• MDR Report Key: 6562722
• MDR Text Key: 75000508
• Report Number: 3007420694-2017-00113
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: FXX21C4B1AAABB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/12/2017
• Distributor Facility Aware Date: 04/12/2017
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/12/2017
• Date Manufacturer Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2016
• 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): Other
• Patient Age: 80 YR
• Patient Weight: 166