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 Pressure Sores (2326)

Event Date 01/19/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2015, it has been reported to arjohuntleigh that there was a problem with auto logic system.It was stated that the mattress was deflating, was only half filled with the air, however, the pump did not show any alarm.The pt developed pressure ulcer due to defective pump.

• Brand Name: AUTO LOGIC
• Manufacturer (Section D): GETINGE (SUZHOU) CO. LTD.; no. 158 fangzhou road; sip, suzhou, jiangsu,; suzhou
• Manufacturer (Section G): GETINGE (SUZHOU) CO. LTD.; no. 158 fangzhou road; sip, suzhou, jiangsu,; suzhou
• Manufacturer Contact: pamela wright ; 12625 wetmore ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4561792
• MDR Text Key: 48982306
• Report Number: 3005619970-2015-00006
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/29/2015

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?: Yes
• Device Operator: No Information
• Device Model Number: 630004DK
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/26/2015
• Distributor Facility Aware Date: 01/29/2015
• Device Age: 3 NA
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2015
• Initial Date Manufacturer Received: 01/29/2015
• Initial Date FDA Received: 02/27/2015
• Date Device Manufactured: 12/01/2012
• 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 Age: 71 YR
• Patient Weight: 85