MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE PLEXOLONG SONO; ANAESTHESIA CONDUCTION KIT

Model Number 521157-31C

Device Problem Partial Blockage (1065)

Patient Problem Awareness during Anaesthesia (1707)

Event Date 11/11/2015

Event Type  malfunction  

Manufacturer Narrative

The device is not available.The data reported is very poor.As soon as further information will be made available through direct investigation with the distributor, a follow up report will be sent to fda.In case no further information becomes available, we consider this case as closed and no follow up will be sent.Device unavailable.

Event Description

(b)(4).Event took place in (b)(6).Reporter's narrative: catheter, filter or adapter blocked.

Manufacturer Narrative

The device is not available.The data reported is very poor.Only "fragments" of the original device kit have been returned for investigation.No failure was detected.This file is considered as closed.

Event Description

(b)(4).Event took place in (b)(6).Reporter's narrative: catheter, filter or adapter blocked.

• Brand Name: PLEXOLONG SONO
• Type of Device: ANAESTHESIA CONDUCTION KIT
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• Manufacturer Contact: christian quass ; karl-hall-str. 1; regulatory & safety affairs; geisingen, baden-wuerttemberg 78187 ; GM 78187 ; 7704929158
• MDR Report Key: 5446609
• MDR Text Key: 39116496
• Report Number: 9611612-2016-00007
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K113188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/04/2016

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: Health Professional
• Device Model Number: 521157-31C
• Device Catalogue Number: 521157-31C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/28/2016
• Initial Date FDA Received: 02/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other