MAUDE Adverse Event Report: 10031#AVALON ELITE 31F, 31CM

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Event Description

(b)(4).

Manufacturer Narrative

(b)(4).Maquet cardiopulmonary (b)(4) has not received the device for eval.The product failure investigation, analysis and resolution for the device described in this report will be provided by maquet cardiopulmonary (b)(4).A supplemental medwatch will be provided when add'l info becomes available.(b)(4).

• Brand Name: 10031#AVALON ELITE 31F, 31CM
• Type of Device: AVALON ELITE 31F, 31CM
• Manufacturer Contact: michael campbell ; kehler str. 31; rastatt 76437 ; GM 76437 ; 2229321132
• MDR Report Key: 4514326
• MDR Text Key: 5441534
• Report Number: 8010762-2015-00058
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K081820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Type of Report: Initial
• Report Date: 02/11/2015

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?: No
• Device Operator: Other
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/13/2015
• Date Report to Manufacturer: 01/13/2015
• Initial Date Manufacturer Received: 01/13/2015
• Initial Date FDA Received: 02/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 51 YR