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

Model Number 630004DK

Device Problem Defective Alarm (1014)

Patient Problems Death (1802); Pressure Sores (2326)

Event Date 08/03/2016

Event Type  Death  

Manufacturer Narrative

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

Event Description

On 25th oct 2016 arjohuntleigh received an information about an incident which occurred on auto logic system.It was reported that the patient ((b)(6) demented woman) was laying on a flat mattress and the pump did not give any alarm.During the night watch it was discovered that the patient has suffered from a pressure ulcer on the right hip.The patient has already had 7 decubitus located on legs, feet and os sacrum, which she was hospitalized for.The patient died 3 days after the incident, on (b)(6) 2016, however, it was indicated by the facility that the additional pressure ulcer she developed due to the system malfunction was not directly linked to her death.She had a very poor blood flow below the knees with the (b)(6).As per facility: "she was at a state in her life were it was an ethical decision whether she should receive treatment or not.The additional pressure ulcer she got on the hip due to a flat mattress was not directly linked to her death.But it was another push in that direction.".

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.Based on the information received, the patient ((b)(6)-old female with dementia) was laying on a deflated auto logic mattress and the pump did not give any alarm.During the night watch it was discovered that the patient has suffered from a pressure ulcer on the right hip (the ulcer stage was unknown).The patient died 3 days after the incident, on (b)(6) 2016, however, it was indicated by the facility that the additional pressure ulcer she developed due to the system malfunction was not directly linked to her death.She had a very poor blood flow below the knees with a bmi=14.The patient was at a state of her life when it was an ethical decision whether she should receive a treatment or not.When reviewing similar reportable events, we have found (b)(4) other cases presenting a scenario of mattress deflation with no alarm, out of which only (b)(4) records were confirmed to have regarded a particular malfunction of the system.The occurrence rate observed for this failure mode is currently considered to be low.The customer did not register any serial numbers of the pump or mattress, leaving us with no possibility to trace the system or look for service history.Available information did not allow to conclude on the root cause of the reported problem.It was reported that the patient was laying on a flat mattress which clearly indicates a low pressure condition which occurred in the system.A low pressure is usually a result of air leakage within the pump or mattress assembly or an insufficient air supply.There are various components of auto logic system which may be a potential cause of leakage.Initially, when the leakage is insignificant, the pump aims to compensate the level of pressure through an excessive operation of the compressor.When the level of pressure decreases below a designed level, normally a low pressure alarm is triggered.Also, it is not impossible that there was no device malfunction and the alarm was triggered but was ignored and/or that the mattress was simply not put into functioning and slowly deflated as a consequence.Taking into consideration pre-existing severe condition of the patient it is possible that the reported pressure sore has been developed even within the first 30 minutes of a low pressure condition, before any alarm was triggered and launched.Due to the health condition factor the patient was probably under an intense medical supervision, however, it appears the monitoring did not help prevent from the outcome for patient.It was not confirmed that the alarm on pump was non-functional, however, in the worst case scenario, the potential failure of the low pressure alarm may be a result of faulty pcb or a pcb battery which is responsible for the alarm.The exact root cause of the investigated issue is not possible to be defined as none of the above scenarios were confirmed.It has been established that the auto logic system was being used for a patient therapy at the time of the event and has contributed to the outcome of the event.It is most likely that the system has malfunctioned (did not perform up to specification) when the event took place.It appears reasonable to conclude that the potential malfunction itself did not result in patient's death.A deterioration of already poor health condition was a combination of factors, diseases and circumstances.The stage of developed pressure sore was unknown, however, there was no indication of a serious type of this injury.

• Brand Name: AUTO LOGIC
• Type of Device: FNM
• Manufacturer (Section D): GETINGE (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu, 21502 4; CH 215024
• Manufacturer (Section G): GETINGE (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu, 21502 4; CH 215024
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 6073647
• MDR Text Key: 58979405
• Report Number: 3005619970-2016-00021
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 12/02/2016,10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: 630004DK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/02/2016
• Distributor Facility Aware Date: 10/25/2016
• Event Location: Hospital
• Date Report to Manufacturer: 12/02/2016
• Initial Date Manufacturer Received: 10/25/2016
• Initial Date FDA Received: 11/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death
• Patient Age: 80 YR