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

Model Number 630004DK

Device Problem Defective Alarm (1014)

Patient Problem Pressure Sores (2326)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2016 arjohuntleigh received information about an incident which occurred on auto logic system.An amputated elderly male at risk for pressure ulcers who was hospitalized due to an ulcer was found on a very soft mattress.The pump did not give any alarm.The patient has suffered from a pressure ulcer (category 1) which was observed after the incident.The pressure ulcer disappeared after a few days.According to the clinical expert, this injury was not assessed as serious.The technical investigation showed that the pump battery responsible for the alarm was out of function.

Manufacturer Narrative

This report is being filed under exemption (b)(4) by getinge ((b)(4)) co., ltd.(registration #(b)(4)) on behalf of the importer arjohuntleigh, inc.(b)(4) ((b)(4)).An investigation was carried out into this complaint.Based on the information received, an amputated elderly male patient at risk for pressure ulcers was hospitalized due to an ulcer and was using auto logic system.The patient was found on a very soft mattress.The pump did not give any alarm.The patient has suffered from a pressure ulcer (category 1) which was observed after the incident.The pressure ulcer disappeared after a few days.According to the clinical expert opinion, this injury was not assessed as serious.As a result of performed service there were two pump components replaced - a pcb battery and a bed hook.The technical investigation showed that the pump battery responsible for the alarm was out of function.The bed hook was replaced due to a worn coating.When reviewing similar reportable events, we have found 6 other cases presenting a scenario of mattress deflation with no alarm, out of which only three 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.Available information allowed to conclude that root cause of the reported problem is related to the malfunction of pcb battery.It was reported that the patient was laying on a soft mattress which clearly suggests that a low pressure condition 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.Basing on the replaced pump components (pcb battery and bed hooks), none could be responsible for the air leakage.It was not possible to examine the mattress but it is very likely that the problem which initiated a low pressure was localized in mattress assembly.Unfortunately, the serial number of the involved mattress was not provided.It was indicated by the facility that during the reported event there was no low alarm launched.Pcb battery was found to have been non-functional.The failure of pcb battery (responsible for the alarm) may have various roots: - lack of regular control of battery functionality - its functionality is disturbed when the pump is not in use for a longer period.According to the supplier specification, a cycle or activation (charge and recharge) should be done on battery every 6-9 months - non-confirm part delivered from supplier - environmental conditions and other accidental factors (such as frequent power supply errors) - wear of the component.The possible sequence of events presented above seems to be the most probable and in line with the event description.The exact root cause of the pcb battery failure was not possible to be defined as none of the above scenarios could have been 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.

• 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
• 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: 6091917
• MDR Text Key: 59773698
• Report Number: 3005619970-2016-00022
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/09/2016,10/12/2016

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: Other
• Device Model Number: 630004DK
• 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: 12/09/2016
• Distributor Facility Aware Date: 10/12/2016
• Event Location: Hospital
• Date Report to Manufacturer: 12/09/2016
• Initial Date Manufacturer Received: 10/12/2016
• Initial Date FDA Received: 11/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2013
• 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