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

Model Number ALT01

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Date 02/19/2014

Event Type  malfunction  

Event Description

It has been reported that a maintenance man, plugged in the pump in order to test it prior putting into service and prove the pump was in working order.Pump was left on test in a room.After a period of time a smell of burning/over heating was coming from the pump, therefore, staff broke the fire alarm glass and took the pump outside.It was reported that the pump overheated, blistered and was smoking.Reference mfr report # 3005619970-2014-00005.

• 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): ARJO, INC.; 50 north gary ave., suite a; roselle IL 60172 168
• Manufacturer Contact: 50 north gary ave., suite a; roselle, IL 60172-1684
• MDR Report Key: 3716317
• MDR Text Key: 4337234
• Report Number: 1419652-2014-00074
• Device Sequence Number: 1
• Product Code: FNM
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2014,02/21/2014

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: Other
• Device Model Number: ALT01
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/21/2014
• Distributor Facility Aware Date: 02/21/2014
• Event Location: Nursing Home
• Date Report to Manufacturer: 03/21/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/25/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other