MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP Z O.O ENTERPRISE 5000X; BED, AC-POWERED ADJUSTABLE HOSPITAL

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Bruise/Contusion (1754); Swelling (2091)

Event Date 01/02/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusions of the investigation.

Event Description

On (b)(6) 2019 arjo has been informed about the event, which took place when the patient was using the adjustable strap and handle in order to lift herself up when the handle strap broke and fell on the patient's right eye.The device was taken out of use right after the incident.As the consequence of this event, patient sustained swelling and bruising of the patient's eye.

Manufacturer Narrative

On (b)(6)2019 arjo has been informed about the event, involving enterprise 5000x which occurred in az west hospital located in veurne in belgium.It was reported that when the patient was using the adjustable strap and handle in order to lift herself up when the handle strap broke and fell on the patient's right eye.The device was taken out of use right after the incident.As a consequence of this event, the patient sustained swelling and bruising of the patient's eye.The patient using a lifting pole with adjustable handle and strap was weighing 90 kg.The patient involved in the incident was classified as albert' according to arjo mobility gallery - what means that the patient may require special aids or appliances.Generally, there is no risk of physically overloading the caregiver.Albert requires careful monitoring.The arjo representative arrived at the facility for device evaluation.The inspection showed that the part was cracked over the entire width.During the visit at the customer side, it was clarified that in the time when the event occurred the patient tried to stand up in the bed, and used the adjustable strap and handle for this purpose.The defective adjustable strap has the tractability mark showing that it has been manufactured on may 2008, making the item approximately 11 years old at the time of the event (awareness date march- 2019).In order to reduce the risk of the patient using the device over its lifetime, the product instruction for use (e.G.746-439 rev.9) informs: "the operational life of the strap and handle is five years when used and maintained in accordance with the manufacturer's instructions.After this time the complete unit should be replaced".Additionally, the ifu indicates not to exceed maximum safe working load of the device: "do not exceed the safe working load of 75kg (165lb)" based on the information collected to date, provided problem description and photographic evidence, it has been found that the patient using a lifting pole with adjustable handle and strap was weighing 90 kg.The facility staff member confirmed that the patient was using part to stand in the bed.Taking into account all the above it appears that this particular failure is the result of inappropriate use of the product (safe working load exceeded) and prolonged use of the strap and handle against the recommendation provided in product instruction for use.To sum up, although there were no serious injuries reported, the complaint was decided to be reportable due to adjustable handle breakage while being in use.The accessory was reported to break and from that perspective the item did not work up to manufacturer's specification.

Manufacturer Narrative

Collected information are currently analyzed.Additional information will be provided upon investigation conclusion.

• Brand Name: ENTERPRISE 5000X
• 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
• MDR Report Key: 8490828
• MDR Text Key: 145789158
• Report Number: 3007420694-2019-00060
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/05/2019
• Distributor Facility Aware Date: 03/14/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/05/2019
• Date Manufacturer Received: 04/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 90