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

Model Number 630009AU

Device Problems Break (1069); Circuit Failure (1089)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Arjo was notified about an incident involving auto logic pump.It was reported by the customer, that when a nurse turned on the tv set using switch at a power board located on a wall (and not a tv set handset), a very loud bang was heard which frightened the nurse and a patient (who was sitting on arjo aura cushion at that time).The pump was attached the power board as well.As described by the customer, there was a smell of burning plastic or rubber.Based on the photographic evidence, black marks on pump casing were visible due to power cord damage.The pump was disconnected from the electrical appliance and withdrew from use.There was no injuries in regards to the reported issue.

Manufacturer Narrative

We (arjo) are still waiting for the test results from the supplier evaluation.Additional information will be provided upon conclusion of the manufacturer's investigation.

Manufacturer Narrative

The investigation has been performed to the damaged power cord and the conclusions are following.Arjo was notified about an incident involving auto logic pump.It was reported by the customer, that when a nurse turned on the tv set using a switch at a power board located on the wall (and not a tv set handset), a very loud bang was heard which frighten the nurse and a patient (who was sitting on arjo aura cushion at that time).The pump was attached to the power board as well.As described by the customer, there was a smell of burning plastic or rubber.The pump was disconnected from the electrical appliance and withdrew from use.There was no injuries in regards to the reported issue.Photographic evidences of the device were provided.The pump had visible black marks on the outer casing, the power cord was damaged, a cut to the power cord was close to the iec connector cover (part number 630329).The involved pump was inspected prior to releasing for rent on 28 aug 2018.It was repaired and then electrically tested.No fault was detected related to the power cable.After the event, the pump was checked by arjo service technician and no damages or sharp edges in the pump casing that would explain the reason for power cord damage could be found.Later the cable was sent for further inspection to the manufacturer, who concluded that test was not required as the power cord was broken and damaged.The power cord was in use, at least since 2014 (4 years).The pump was manufactured in 2004.Further, we have checked the pump service history records and found out that on 9 jun 2018 the pump had been dropped, and as a result needed to have a new case fitted including an item 630329 (iec connector cover), which covers the entry, of the power cord, to the pump.Based on the gathered data, we have concluded, that the cable could have been damaged in june, when the pump had been dropped.The micro cut could occur due to the damaged iec connector cover and was not detected during cable visual and electrically test.The small, undetectable cut could further lead to the power cord failure during use.In summary, the arjo auto logic pump was used for patient treatment when the event occurred and therefore played role in the incident.The power cord had been damaged and from that perspective it did not meet the manufacturer specification.We report this event due to its nature since the failure was not detected immediately and the pump was left in use until the event occurred, which might lead to hazardous situation.

Manufacturer Narrative

Test report of the power cable was approved on 3 apr 2019.The cable was not tested because the electrical wires were broken and damaged.According to the label attached to the power cord, it passed the flow test in service center in australia on 14 may 2018.Currently, we are gathering all the information presented in the test report in order to compile it in final report.As soon as investigation conclusion will be available, a follow-up report will be submitted.

Manufacturer Narrative

Manufacturer visually inspected the power cable.Currently we are waiting for the report from that inspection.As soon as it will be available, the final report will be provided.

Manufacturer Narrative

Because the supplier evaluation did not reveal that the cable was manufactured by them, the component was sent to manufacturer for further evaluation.Manufacturer received the package on 31 jan 2019.We are waiting for the evaluation conclusions.

Manufacturer Narrative

Currently, we are waiting for the test results from the supplier evaluation.When the information is available a follow-up report will be provided.

• Brand Name: AUTOLOGIC
• 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
• MDR Report Key: 8101843
• MDR Text Key: 128287283
• Report Number: 3005619970-2018-00013
• Device Sequence Number: 1
• Product Code: FNM
• 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,Followup,Followup
• Report Date: 05/13/2019

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: Health Professional
• Device Model Number: 630009AU
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/13/2019
• Distributor Facility Aware Date: 10/29/2018
• Device Age: 14 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/13/2019
• Initial Date Manufacturer Received: 10/29/2018
• Initial Date FDA Received: 11/26/2018
• Supplement Dates Manufacturer Received: 10/29/2018; 10/29/2018; 01/31/2019; 01/31/2019; 04/03/2019; 04/03/2019
• Supplement Dates FDA Received: 12/19/2018; 01/09/2019; 03/01/2019; 03/29/2019; 04/25/2019; 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other