MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. ZO.O. MINUET

Model Number 160AA2A1A

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2014

Event Type  malfunction  

Event Description

It has been indicated by the customer (community equipment store) that the bed's welds failed.Customer has concluded that this was due to misuse, as the (b)(6) stone pt was 'bouncing' on the bed when he repositions himself.The event was not witnessed, exact circumstances under which the failure occurred are unk.No info about any injuries sustained.

Manufacturer Narrative

(b)(4).When reviewing similar reportable events for minuet 2 devices, we have found four cases with similar fault description compared to the one investigated here: the weld failure on the head end or/and foot end panel.One event occur in the (b)(6) and three in the (b)(6).There was no report of injury during this instance.There is no trend observed for the reportable complaints with this failure mode for minuet 2 bed.Taking into consideration that over (b)(4) minuet beds have been sold since 2004, the complaint ratio is considered to be low - the failure rate is below (b)(4) against the installed base.The product involved in the incident is an minuet 2 bed, model 160ca2a1a, serial number (b)(4), which was purchased to the customer on (b)(4) 2008 and has been in use with the same client since (b)(4) 2008.It is also worth noting that at the time of the incident ((b)(6) 2014) that as the bed was over 6 years old and we are not aware of any other problems with the bed prior to the incident.Based on the provided info, it has been determined that the abutment of two inner tubes that form the telescopic lifting columns on the head/foot end sections of the bed to the base cross member has broken away.There has been no actual weld failure as the weld has remained intact with good penetration into the parent metals of the component parts.But there has been a fatigue fracture in the base cross member around the outer edges of the abutment welds that secure the tubes to the cross member which has resulted in two discs of metal being pulled out of the cross member.Unfortunately, without having detailed witness description of what occurred, we are left to review the info received from the customer per out best efforts, and compare it to our product knowledge that in part comes from previous complaint investigations.The most probable cause of this fracture is the load and impact applied on the bed when the pt was continuously repositioning himself on the bed- when the bed is used at height with a high load, cyclic load on the base cross member is occurring.Product instructions for use document (e.G.# 746-396_4) which was supplied to the customer together with the claimed device-informs the user in section 8.Maintenance, that the preventive maintenance procedures should be carried out at intervals of 12 months.During this service procedure bed should be examined for obvious signs of damage.All aspects of the equipment should operate as intended.Unfortunately, we have not received any service/maintenance history against the device, so we are not in a position ot determine if adequate preventative maintenance was performed on it in accordance with our recommendations.In summary the device failed to meet specifications, it is unk if the device was being used at the time of the event, however, no injuries were sustained.Given the circumstances and the number of products in the market this incident and the previous one represent a failure rate of (b)(4) of our installed base.We consider these events to be a remote issue, we shall continue to monitor for any further events of this nature but do not propose any further action at this time.

• Brand Name: MINUET
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki; poznan 6205 2; PL 62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki; poznan 6205 2; PL 62052
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4339796
• MDR Text Key: 5205506
• Report Number: 3007420694-2014-00132
• Device Sequence Number: 1
• Product Code: LLI
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 11/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 160AA2A1A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/09/2014
• Distributor Facility Aware Date: 11/11/2014
• Date Report to Manufacturer: 12/09/2014
• Date Manufacturer Received: 11/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 127