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

Model Number 160CA2A1A

Device Problems Break (1069); Detachment Of Device Component (1104); Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/07/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).When reviewing similar reportable events for minuet 2 devices, we have found three 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 occurred in (b)(6) and two 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.(b)(4).The product involved in the incident is an minuet 2 bed, model 160ca2a1a, serial number (b)(4) which was manufactured on 02/27/2008.It is worth noting at the time of the incident ((b)(6) 2014) that 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 information 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.The most probable cause of this fracture is an overload fatigue failure, likely as the result of the bed having been used at height with a high load, causing cyclic load on the base cross member.Given the failure mode of the fracture we believe that overloading of the bed has occurred at some point in its history which has led to the subsequent failure of the bed.Typically, these beds are not assigned to one patient, they are occupied by a number of people during the bed lifetime.Therefore the information about the last user's weight does not allow us to assess whether the bed was overloaded in the past.Additionally, patient who used the bed at the time of event has been described as constantly shifting her weight.Product instructions for use (e.G.#746-396_4) - which was supplied to the customer together with the claimed device - informs the user in section 2.Applications inform the user that the safe working load of the bed is 180 kg.Additionally, section 8 of the product instructions for use - maintenance, inform the user that preventive maintenance procedures should be carried out at intervals of 12 months.During this service procedure the 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 to determine if adequate preventative maintenance was performed on it in accordance with our recommendations.In summary the device failed to meet specifications, was being used at the time of the event and therefore played a role in 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 (b)(4).We consider these events to be an issue of remote likeliness, we shall continue to monitor for any further events of this nature but do not propose any further action at this time.

Event Description

It has been initiated by the facility that the welds on the foot end of the bed were found to be broken completely where the main columns meet the horizontal leg box section.Arjohuntleigh was informed that the patient using the bed at the time of the event is constantly shifting her weight.Fortunately, there were no injuries sustained as a result of the event.This is being reported as if this type of malfunction were to recur it may cause or contribute to a serious injury.

• Brand Name: MINUET
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki; poznan 62052 ; PL 62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. piotra wawrzyniaka 2; komomiki PL 62 052; PL PL 62052
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste. 308; san antonio, TX 78247-0000 ; 2102787040
• MDR Report Key: 4147724
• MDR Text Key: 51018477
• Report Number: 3007420694-2014-00087
• 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: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 09/03/2014,08/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 160CA2A1A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/03/2014
• Distributor Facility Aware Date: 08/07/2014
• Event Location: Nursing Home
• Date Report to Manufacturer: 09/03/2014
• Date Manufacturer Received: 08/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2008
• 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: 70 YR