MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP.Z O.O. ACCESSORIES - MEDICAL BEDS (LIFTING POLE); APPARATUS, TRACTION, NON-POWERED

Model Number 805.855

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Following the information provided a strap and triangle being a part of a lifting pole accessory broke.

Manufacturer Narrative

This report is being filed under exemption e2012070 by arjohuntleigh polska sp.Z o.O.(registration#(b)(4)) on behalf of the importer arjohuntleigh, inc.(ahus) (registration# (b)(4)).On (b)(6) 2018 arjo was informed about the complaint involving accessory, adjustable lifting handle.The malfunction took place in strasbourg chu hospital civil in france.Following the information provided the adjustable lifting handle broke while the patient was using the accessory in order to reposition himself on the bed.As a result, the patient did not sustain any injury.Based on the information collected to date, provided problem description and photographic evidence, it has been found that the actual piece that has broken is the belt retractor housing which provides the adjustment of the strap.The defective adjustable strap has the tractability mark showing that it has been manufactured on (b)(6) 2007, making the item almost 10.5 years old at the time of the event on ((b)(6) 2018).The accessory was not under arjo service contract.The frequency and scope of the maintenance activities performed on the involved product remains unknown.In order to reduce the risk of patient using the device over its lifetime, the product instruction for use (e.G.746-439 rev.8) 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".Taking into account all the above it appears that this particular failure is the result of prolonged use of the adjustable lifting handle.Although there were no injuries reported, the complaint was decided to be reportable due to adjustable handle breakage.There was no indication of patient's involvement at the time of the malfunction occurrence.The accessory was reported to break and from that perspective the item did not work up to manufacturer's specification.

• Brand Name: ACCESSORIES - MEDICAL BEDS (LIFTING POLE)
• Type of Device: APPARATUS, TRACTION, NON-POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP.Z O.O.; ul. ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• MDR Report Key: 7439486
• MDR Text Key: 106338583
• Report Number: 3007420694-2018-00094
• Device Sequence Number: 1
• Product Code: HST
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 805.855
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/18/2018
• Distributor Facility Aware Date: 03/20/2018
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/18/2018
• Date Manufacturer Received: 04/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other