MAUDE Adverse Event Report: GETINGE (SUZHOU) CO., LTD. ALPHA TRANCELL DELUXE

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

This report is being filed under exemption (b)(4) by arjohuntleigh, inc.On behalf of the manufacturer (getinge ((b)(4)).(b)(4).Additional information will be provided upon conclusion of the manufacturers investigation.

• Brand Name: ALPHA TRANCELL DELUXE
• Manufacturer (Section D): GETINGE (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu 2150 24; CH 215024
• Manufacturer (Section G): GETINGE (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu 2150 24; CH 215024
• Manufacturer Contact: pamela wright ; 12625 wetmore; ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 3716289
• MDR Text Key: 4236050
• Report Number: 3005619970-2014-00005
• 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: Consumer
• Remedial Action: Replace
• Type of Report: Initial

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?: No
• Device Operator: Other
• Initial Date Manufacturer Received: 02/21/2014
• Initial Date FDA Received: 03/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1