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

Model Number 630001

Device Problem Decrease in Pressure (1490)

Patient Problem Tissue Damage (2104)

Event Date 04/08/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The investigation by the reporter that mattress fault reported to (b)(6) (from which the device was rented); sacrum under observation by staff be provided upon conclusion of the investigation.(b)(4).

Event Description

On june 29, 2015, arjohuntleigh received a report from (b)(6) referring to an adverse incident that occurred on (b)(6) 2015.On (b)(6) 2015, a district nursing sister and a tissue viability nurse were attending a pt regarding a different issue and discovered the cells of the auto logic mattress to be very soft around the sacral area of the bed.Pt was being nursed in bed.

Manufacturer Narrative

(b)(4).On 29 jul arjohuntleigh become aware that on (b)(6) 2015 two facility staff - tissue viability nurse and district nursing sister were attending a patient (in her private residence) regarding a different issue and discovered that the cells of the auto logic mattress were very soft around the sacral area of the bed.Patient suffered deep tissue injury to sacrum.The patient was being nursed in bed.Additional information revealed by the nurse advisor: the patient was discharged from hospital at the end of (b)(6) 2015, her sacrum and skin were checked the weekend of her discharge (b)(6).The skin was intact and healthy and left exposed.The patient was being nursed on an auto logic mattress.She was receiving five calls a day from care providers who repositioned her each call and would have carried out skin checks.The patient was admitted to the district nursing list for twice weekly calls for dressing to pressure damage to her heels.At the day of the event - (b)(6) 2015, the patient was seen by tissue viability nurse and district nursing sister.The sacrum was checked and an area of 8x8cm of blanching erythema was discovered.The mattress appeared to be faulty.An urgent call was made to the local equipment store for repair.The skin breakdown on sacrum needed dressings.Mattress was checked by district nursing staff and deemed to be working.At present the patient continues with five times a day repositioning for personal care and daily calls from district nursing.The product involved in the complaint is auto logic system; pump serial number is (b)(4) (manufacturing date: 14 jan 2012).The device was ordered by (b)(4) but in fact ot was used in the patient private residence.The device was under arjohuntleigh service contract by end of april 2015.Since 01 may 2015 the service is being provided by 3rd party - (b)(4).At the same day the event occurred, the device was taken out of service and sent to the storage facility for this trust, where arjohuntleigh technician came and performed a repair).Upon the unit inspection it turned out that the manifold is damaged and requires replacement.No other malfunctions have been noted.The system was tested and put back to service.Worth to note is the fact that the system is designed in the way to alert the user about the malfunction/interruption in the therapy and is launching the alarm once the low pressure state in system occurs.The alarm function (audio and visual) acts as an early warning system for the user and notify about the problem.We have no evidence that would suggest the alarm was not working properly.This is the first complaint since 2010 on auto logic system in which there is an allegation that manifold failure caused or contributed to disruption in therapy and resulted in injury occurrence.(b)(4).In summary, the device was being used at the time of the event, it failed to meet its specifications as it suffered a malfunction due to component failure and in doing so it contributed to the outcome of the event - the patient tissue damage to the sacrum, however the mitigations for this to happen were in place and there is no indication they failed.Therefore we can assume the designed-in mitigation was not followed up on as required by the device labelling and its intended use, and can therefore be related to a use error.

• Brand Name: AUTO LOGIC
• Manufacturer (Section D): GETINGE (SUZHOU) CO. LTD.; no. 158 fangzhou road sip; suzhou, jiangsu ; CH
• Manufacturer (Section G): GETINGE (SUZHOU) CO. LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu ; CH
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 5006937
• MDR Text Key: 23244220
• Report Number: 3005619970-2015-00010
• 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: company representative,health
• Reporter Occupation: Nurse
• Remedial Action: Patient Monitoring
• Report Date: 09/03/2015,07/29/2015

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?: No
• Device Operator: Nurse
• Device Model Number: 630001
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/03/2015
• Distributor Facility Aware Date: 07/29/2015
• Device Age: 3 YR
• Event Location: Home
• Date Report to Manufacturer: 09/03/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2015
• 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