MAUDE Adverse Event Report: GETINGE (SUZHOU) CO., LTD. AUTO LOGIC; FNM

Model Number 630004SV

Device Problems No Audible Alarm (1019); Decrease in Pressure (1490)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/27/2016

Event Type  malfunction  

Manufacturer Narrative

This report is being filed under exemption (b)(4) by getinge (suzhou) co., ltd.(b)(4) on behalf of the importer arjohuntleigh, inc.Ahus (b)(4) additional information will be provided upon conclusion of the investigation.

Event Description

On (b)(6) 2016 arjohuntleigh received a customer complaint where it was indicated that on (b)(6) 2016 the patient was placed on the auto logic mattress and the next day in the morning the patient was found lying through the mattress directly on the bed.The mattress was deflated.The patient was placed on a new mattress, and no injuries were sustained.Arjohuntleigh rental technician was with the customer this morning and could conclude that it was the pump which have failed.It was noticed that the auto logic pump didn't give any alarm.The auto logic mattress involved works fine and is still in use at the facility.The pump was switched to a new pump.

Manufacturer Narrative

An investigation was carried out into the complaint.Arjohuntleigh received a customer complaint where it was indicated that the patient was placed on the auto logic mattress and the next day in the morning was found lying on the mattress directly on the bed.The mattress was deflated and it was indicated that nobody heard the alarm sound.The patient was placed on a new mattress, and no injuries were sustained.When reviewing similar reportable events, we have found a number of cases associated with malfunction of pump alarm activation when the low pressure in the mattress occurred, however the reasons of these were multiple.The trend observed for reportable complaints with this failure mode is currently considered to be very low.It can be established that the auto logic system was being used for patient care when the event took place and in that way contributed to the outcome of the event.The system was checked by our technician.The auto logic mattress was found in good condition "works fine and is still in use at the facility".The auto logic pump was found not working - the print circuit board (pcb) was indicated to be faulty.Following the above, it can be established that the auto logic system was found to have malfunctioned (not to specification) when the event took place.The history review showed that no defects were found when the pump was released the factory.The product passed all functional tests and operated within its specification.The faulty auto logic pump was returned to the manufacturer for further evaluation and was found with no activity after ac power application.The analysis of the pump revealed that the reg1 component on the pcb ((b)(4)) is cracked.Therefore, the device is completely powered off.Reg1 component controls the flyback converter block which is used to generate dc power for system from ac mains.Reg1 component failure causes the system power non-presence and therefore the system is shutting down.There is no ability to generate any alarm in this case.After replacement of the (b)(4) power supply board the pump can power up normally.The design of (b)(4) board has been proved by emc certification test.Reg1 component failure was never detected in the past and therefore, the issue investigated here is an isolated instance reported to date.At this point there are no further possibilities to trace and determine the root cause base on the one failure reported.Monitoring of (b)(4) failures in the future will help to collect enough data and find the root cause.The patient did not sustain any injuries as a result of the event.However in the event of loss of pressure in the system, as reported here, the therapy provided is reduced and the risk of the development of a pressure sore increases (if left unattended).Because of this possibility, we decided to report this event to competent authorities.

• Brand Name: AUTO LOGIC
• Type of Device: FNM
• Manufacturer (Section D): GETINGE (SUZHOU) CO., LTD.; no. 158 fangzhou road; suzhou industrial park; suzhou, jiangsu ; CH
• Manufacturer (Section G): GETINGE (SUZHOU) CO., LTD.; no. 158 fangzhou road; suzhou industrial park; suzhou, jiangsu ; CH
• Manufacturer Contact: pamela wright ; 12625 wetmore,; ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 5450340
• MDR Text Key: 38640983
• Report Number: 3005619970-2016-00001
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 06/08/2016,01/28/2016

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: 630004SV
• 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: 06/08/2016
• Distributor Facility Aware Date: 01/28/2016
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/22/2016
• Initial Date Manufacturer Received: 01/28/2016
• Initial Date FDA Received: 02/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2016
• 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