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

Model Number 630004FR

Device Problems Insufficient Information (3190); Unclear Information (4052)

Patient Problem Death (1802)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a patient died while on a autologic system from unknown reason.The facility is trying to determine the cause.As per complaint description "an autopsy was performed and the patient would have died electrocuted." an arjo technician inspected the pump with the following results: main cable found in good condition, front case has a small hole without any risk of contact to electronic parts, electrical test was done without any sign of failure.Currently, we are gathering information in regards to this event.

Manufacturer Narrative

The customer reported patient's death by electrocution.Because, the patient was found with main cable around his wrist, it was suspected that pump main cable could have been involved in the incident.The staff were in a rush when they found the body; therefore, the circumstances of the event are not clear.The facility staff were not certain if the main cable was from the pump or bed frame, but they suspected that the pump cable was involved.An arjo technician evaluated the pump with the following results: cable isolation was correct; front case has a small hole without any risk of contact to electronic parts; electrical test was done without any signs of failure.It is unknown if the bed frame was also evaluated.The customer performed second autopsy, but the report results were not revealed.No further information regarding the possible cause of patient's death were provided by the customer.The incident occurred in (b)(6) located in france, which is a public mental health facility.It is unknown how the patient had access to the main cable and if use of the main cable might have been intentional.From the performed evaluation, it was determined that arjo device can be excluded as a potential cause of the reported incident.The cable was checked and no wires of the cable were exposed.Electrical test did not show any signs of failure.Photographic evidence provided also proven that regardless of small defects, there was no access to internal wires or pump electrical components.The reported incident is an isolated occurrence.In summary, the auto logic system was used for a patient treatment when event occurred and in that way played role in the incident.Upon investigation and device evaluation it was determined that arjo device could not have been the cause or in any way contributed to the reported outcome.The reported event is not related to the arjo device performance.

• Brand Name: AUTOLOGIC
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING
• Manufacturer (Section D): GETINGE (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu, 21502 4; CH 215024
• MDR Report Key: 7680875
• MDR Text Key: 113739232
• Report Number: 3005619970-2018-00010
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 08/03/2018

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: Lay User/Patient
• Device Model Number: 630004FR
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/03/2018
• Distributor Facility Aware Date: 07/10/2018
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/03/2018
• Initial Date Manufacturer Received: 07/10/2018
• Initial Date FDA Received: 07/12/2018
• Supplement Dates Manufacturer Received: 07/25/2018
• Supplement Dates FDA Received: 08/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death