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

Model Number 630004DK

Device Problems No Audible Alarm (1019); Decrease in Pressure (1490)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2015

Event Type  malfunction  

Event Description

On (b)(6) 2014 the following was reported to arjohuntleigh: a pt was placed on the auto logic mattress system.When the pump was connected to the power source, the service light was flashing.The caregivers thought that it would not influence the work of the pump.After several hours the pt was laying on the bed base frame.There was only air in the head and foot section.Additionally no alarm for "too low pressure" was present.Once this was noticed the pt was moved onto a new auto logic system, however just like the other system, the mattress lost air and no low pressure alarm was present as well.The caregivers had to press the button on the pump to keep some air in the mattress.No injuries were reported, pt discomfort only.

Manufacturer Narrative

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

• Brand Name: AUTO LOGIC
• Manufacturer (Section D): GETINGE SUZHOU CO. LTD.; no. 158 fangzhou road; sip, suzhou, jiangsu,; suzhou ; CH
• Manufacturer (Section G): GETINGE SUZHOU CO. LTD.; no. 158 fangzhou road; sip, suzhou, jiangsu,; suzhou ; CH
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4619295
• MDR Text Key: 15347814
• Report Number: 3005619970-2015-00007
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/20/2015

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: Health Professional
• Device Model Number: 630004DK
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/17/2015
• Distributor Facility Aware Date: 02/20/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2015
• Initial Date Manufacturer Received: 02/20/2015
• Initial Date FDA Received: 03/18/2015
• Date Device Manufactured: 01/01/2013
• 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
• Patient Weight: 120