MAUDE Adverse Event Report: IRIS INTERNATIOAL EXPRESS 2; STATSPIN CENTRIFUGE

Catalog Number X00-005222-001

Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 07/21/2014

Event Type  malfunction  

Event Description

Customer reported the unit lid opens during operation.

Manufacturer Narrative

It was reported that the express 2 lid can be disengaged during operation.No pts were harmed.No loss of patient samples nor any injuries or un-contained debris were reported.

• Brand Name: EXPRESS 2
• Type of Device: STATSPIN CENTRIFUGE
• Manufacturer (Section D): IRIS INTERNATIOAL; 9172 eton ave.; chatsworth CA 91311
• Manufacturer Contact: sudha gupta ; 9172 eton ave.; chatsworth, CA 91311 ; 8185277272
• MDR Report Key: 4088582
• MDR Text Key: 4826974
• Report Number: 2023446-2014-00125
• Device Sequence Number: 1
• Product Code: GKG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: X00-005222-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1