MAUDE Adverse Event Report: GETINGE (SUZHOU) CO., LTD. AUTO LOGIC; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 630004DK

Device Problems Computer Software Problem (1112); Failure to Power Up (1476); No Pressure (2994)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2018 arjohuntleigh was informed about an incident which occurred with involvement of autologic system.It was reported that after the power cut, the mattress was found deflated.It was indicated that patient was laying on the mattress for approximately 3-4 hours.The problem was identified in the morning during patient check.There was no injury sustained as a result of this issue.

Manufacturer Narrative

The customer stated that when the event occurred, the pump did not give an alarm.It was not possible to evaluate involved pump since the customer did not register its serial number, but in an attempt to recreate the pump issue, a random sample of pump and battery was checked.Although, the pump failed the same way as reported by the facility, the simulation showed that the pump activated power fail alarm.Therefore, this customer allegation could not have been confirmed.One battery pack involved in the incident was evaluated and found functional, no defect was detected.Further information will be provided upon conclusion of the investigation.Currently, we are in the process of gathering additional information regarding the circumstances of the reported event.

Manufacturer Narrative

A customer reported that "during test of the hfi-relay, the pump turns off and do not switch to the external battery".It was indicated that patient was laying on a bed slats for approximately 3-4 hours ( the time had been estimated based on the time when hfi-test was performed until the moment the pump functionality was restored).After noticing the issue within those 3-4 hours, nurses decided to leave patient on the mattress as it would be more beneficial to the patient than moving them to new mattress.There was no injury sustained as a result of this issue.According to the customer, the pump did not activate an alarm.Although the involved pumps were not evaluated because its serial numbers were not registered by the customer, arjo in attempts to recreate the pump failure, used random pump and battery.During the test, the power was cut off for a short moment to simulate hfi-test.The pump did not switch to the battery mode and back to normal power supply.Based on the tests performed, it was confirmed that the reported condition occurs only on software version v6.2158, under specific conditions: when an external battery pack is fitted into the pump, and when there is short power outage (which lasts less than 5 seconds).It was observed that the pump activated a power failure alarm (visual and audible).The design ensures that alarm (audible and visual) is activated and air-filled sub-mattress (an additional support bottom layer) is not losing air immediately, protecting the patient from immediate harm, because of the pleats built in the sub-mattress the air bleeds slower.The above was confirmed during simulation tests.A dummy weighting 80 kg (176.37 lbs) was placed on the autologic mattress, the pump was forced into the reported failure mode.The overlay top layer of the mattress deflated quickly, but its sub-mattress remained inflated for more than 4 hours supporting the dummy.Based on the simulations, customer allegation regarding pump not switching to the battery pack and back to normal power supply could have been confirmed, an allegation that the pump did not activate an alarm could not have been acknowledged, an allegation that the patient was lying on bed slats could not be acknowledged.Pump failure due to reported software issue, on its own, will not lead to any hazardous situation.Initially, we reported this incident because of customer's allegation that patients were lying on a slats for about 3-4 hours, that there was no alarm activation and probable lack of individualized monitoring which on its own may result in a serious injury.Performed simulations have proven that the system responded as per design, an alarm was activated, and although overlay layer deflated, additional sub-mattress filled with air remained inflated.Therefore, even if there were no alarm, it is unlikely that the reported malfunction would result in patient harm on its own as long as the patient regular monitoring is performed.Caregivers decision to leave the patient on a mattress for 3-4 hours would, also, indicate that there was no immediate risk of serious injury.The system was used for a patient treatment when the event occurred, therefore played role in the incident, it failed to meet its performance specification - the failure was identified as related to software issue.There was no injury sustained and based on simulation tests it is unlikely it will result in any harm in the future.When reviewing reportable complaints for this issue we have found limited number of complaints reported by the same customer, where no injury occurred.For this reason, this type of malfunction is no longer seen as meeting the definition of mdr's and will not be reported to competent authorities in the future.

Manufacturer Narrative

Thus far, we have conducted two simulations, for the pomp itself and a whole system (mattress and pump with software version v6.2158).For the whole system, an arjohuntleigh technician placed dummy weighting 80 kg (176.37 lbs) on the autologic mattress and forced the pump into the failure mode.It was observed that although overlay top layer of the mattress deflated, its sub-mattress remained inflated for more than 4 hours supporting the dummy.Using random samples, we could confirm customer allegation regarding pump not switching to normal power supply, but we could not confirm an allegation that the pump did not activate an alarm and customer allegation that the patient was lying on bed slats.Currently we are reviewing all the information gathered thus far.As soon as the conclusion from the investigation would be available, a follow-up report will be provided.

• Brand Name: AUTO LOGIC
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): GETINGE (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu, 21502 4; CH 215024
• MDR Report Key: 7320144
• MDR Text Key: 102120737
• Report Number: 3005619970-2018-00002
• 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: other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/03/2018

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: 630004DK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/03/2018
• Distributor Facility Aware Date: 02/09/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/03/2018
• Initial Date Manufacturer Received: 02/09/2018
• Initial Date FDA Received: 03/07/2018
• Supplement Dates Manufacturer Received: 02/09/2018; 04/18/2018; 06/15/2018
• Supplement Dates FDA Received: 04/06/2018; 05/11/2018; 07/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other