MAUDE Adverse Event Report: ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB NIMBUS 3 / DFS3; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 151028

Device Problem Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2016

Event Type  malfunction  

Manufacturer Narrative

This report is being filed under exemption (b)(4) by arjohuntleigh (b)(4) sp.Z o.O.(registration #3007420694) on behalf of the importer (b)(4).Please note that previous medwatch reports for this product may have been submitted for the manufacturing site (b)(4).From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh ab's complaint handling establishment and any medwatch reports will be submitted under registration #3007420694.Additional information will be provided upon the investigation conclusion.

Event Description

On (b)(6) 2016 arjohuntleigh has become aware of an event with the involvement of nimbus 3 system.It was reported by the customer that a pump power cord was severed (exposing an internal isolation) which resulted in sparks on the cable.It is unknown whether the sparks were observed during patient's therapy.No injuries resulted from this event.

Manufacturer Narrative

(b)(4).Please note that previous medwatch reports for this product may have been submitted for the manufacturing site arjohuntleigh, a branch of (b)(4).From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh (b)(4) complaint handling establishment and any medwatch reports will be submitted under (b)(4).An investigation was carried out into this complaint.Following the information reported, it was indicated that nimbus 3 pump power cord has been severed and sparks were seen.No injuries to patient resulted from this event.Device was sent to the workshop due to a damaged cord.The pump was inspected and cable insulation cut was detected.After service and electrical test, cord was removed and replaced.Based on the performed interview no injury to patient or caregiver occurred.Moreover, the annual service was performed as its planned date has passed.When reviewing similar reportable events on nimbus system, we have found 2 other cases presenting a similar scenario as claimed in this complaint.The occurrence rate observed for this failure mode is currently considered to be very low.Following the information gathered, personnel probably noticed the malfunction when trying to relocate the bed.It is highly possible that the act of cable damage have occurred during attempt to move the bed (e.G.Damaged by bed castors) or when personnel tried to raise side safety frames, which resulted in the reported symptom.The positioning of the power cable was most likely applied incorrectly.It may be suspected that a defective power cable was not withdrawn from use in a timely manner which have caused sparks.General safety warnings included in instructions for use (document id 151996en_05): "make sure that the mains power cable and tubeset or air hoses are positioned to avoid causing trip or other hazard and are clear of moving bed mechanism or other possible entrapment areas." this possible sequence of events presented above seems to be the most probable and in line with the event description.It was found that the event was most likely caused by use error - not following the ifu guidelines and warnings.Arjohuntleigh suggests to remind the staff involved of the device labeling, with a special attention paid towards a careful device handling and maintenance.This is to be communicated to the customer.Due to the nature of this incident we are reporting this event to competent authorities in the abundance of caution - even though no serious injury occurred, there was a probability of harm with a high severity.It has not been established that the nimbus 3 system was used for patient therapy at the time of the event.Based on the above, the pump was found to have malfunctioned (not performing up to the specification) when the event took place, however, it was concluded that the use error has contributed to the reported event.

• Brand Name: NIMBUS 3 / DFS3
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB; arjohuntleigh house; houghton hall business park; houghton regis, bedfordshire LU5 5 XF; UK LU5 5XF
• Manufacturer (Section G): ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB; arjohuntleigh house; houghton hall business park; houghton regis, bedfordshire LU5 5 XF; UK LU5 5XF
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052 ; 698 282 46
• MDR Report Key: 6206124
• MDR Text Key: 63383295
• Report Number: 3007420694-2016-00264
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: 151028
• 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: 01/25/2017
• Distributor Facility Aware Date: 11/28/2016
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/25/2017
• Initial Date Manufacturer Received: 11/28/2016
• Initial Date FDA Received: 12/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2008
• 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