MAUDE Adverse Event Report: GETINGE (SUZHOU) CO., LTD. FLOWTRON ACS900; SLEEVE, LIMB, COMPRESSIBLE

Model Number 526000-01

Device Problem Infusion or Flow Problem (2964)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2017 arjohuntleigh was informed about an incident which occurred with the involvement of flowtron acs900 pump.It was reported that one of the garments would inflate but not deflate when in use with the patient.No harm to the patient occurred.The pump was immediately tagged out for service and shipped to repair center on the same night.According to the note found inside the box upon opening, "machine alarmed with orange lights that there was a malfunction".After the cleaning procedure was completed, the product was visually inspected and tested.To date no issues with the unit were identified.Testing is still pending.

Manufacturer Narrative

Received pump unit has been tested in the (b)(6).Cycle and electrical testing, operation on battery and alarms functionality testing were performed along with an in-depth analysis of software logs.The analysis did not reveal any abnormal system operation or potential malfunctions.All pressure readings were within specification.Arjohuntleigh has been contacting the reporting facility in order to obtain additional input information regarding observed symptoms and the circumstance of problem occurrence (including the type of involved garments, lcd screen status and operational state of the compressor).At this time it was not possible for the facility to identify the original reporter.Cycle testing is being continued.Additional information will be provided upon the investigation conclusion.

Manufacturer Narrative

Missing udi number was added.

Manufacturer Narrative

Arjo has been contacting the reporting facility in order to obtain additional input information (observed symptoms and the circumstance of problem occurrence).To date it was not possible to gather the information requested.We are in the process of data analysis and forming final conclusions which will be provided upon the final report.

Manufacturer Narrative

An investigation was carried out into this complaint.Based on the information received, a flowtron acs900 pump failed to deflate one of the attached garments when in use with the patient.No harm to the patient occurred.The pump was immediately tagged out for service and shipped to the repair center.Following the note found inside the box upon product's return to service center: "scd machine alarmed with orange lights that there was a malfunction." it was reported that the patient was examined and sustained no harm - the garment was removed from patient's leg.The involved pump was quarantined by the customer and made available for technical evaluation.Involved garments were not returned.Minor scratches were found on the unit surface.A full testing confirmed that the unit operated as expected at the time of examination- passed all the initialization checks and successfully completed a series of cycles.Overall error register showed no records.No application failures detected by the system.The investigation at arjohuntleigh r&d center did not reveal any functional issues with the returned flowtron pump.Software version 2.000 introduced changes to product's reaction when encountering application fault - the pump is supposed to reset automatically in order to come back to the normal operation state.This functionality was tested by providing a specific command to the system.It was confirmed that the feature was working properly.Therefore, from a technical perspective, the investigated pump would have been able to react as intended towards potential application failures detected during device operation.Nevertheless, software logs revealed that the investigated pump has not experienced an application fault.Numerous questions sent to the facility were expected to help steer further investigation.Without obtaining answers which would clarify the exact type of alarm observed and the circumstance of usage we are left with limited possibilities of further investigation.At this point it was not possible to indicate any technical area which might have been responsible for the alleged problem.Cycle testing remains pending under the monitoring.It has been established that the flowtron acs900 pump was used for patient therapy at the time of the event.The system was suspected to have malfunctioned (not performing to specification) when the event took place.However, the unit fault was not confirmed during unit evaluation.

• Brand Name: FLOWTRON ACS900
• Type of Device: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): GETINGE (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu, 21502 4; CH 215024
• MDR Report Key: 7144554
• MDR Text Key: 96024280
• Report Number: 3005619970-2017-00030
• Device Sequence Number: 1
• Product Code: JOW
• 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: 04/27/2018

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: 526000-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/27/2018
• Distributor Facility Aware Date: 11/30/2017
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/27/2018
• Initial Date Manufacturer Received: 11/30/2017
• Initial Date FDA Received: 12/22/2017
• Supplement Dates Manufacturer Received: 11/30/2017; 11/30/2017; 03/15/2018; 03/15/2018
• Supplement Dates FDA Received: 01/19/2018; 02/16/2018; 04/13/2018; 04/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other