MAUDE Adverse Event Report: IRIS INTERNATIONAL STATSPIN MP; STATSPIN CENTRIFUGE

Catalog Number X00-003917-001

Device Problems Component Falling (1105); Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 11/06/2014

Event Type  malfunction  

Event Description

Customer reported that the motor shaft broke.

Manufacturer Narrative

It was reported that the rotor holder shaft broke off causing the rotor to detach from the motor during analysis.The rotor and specimen were contained inside the centrifuge.There was no report of any impact to patient samples.There were no reports of exposure of biohazardous to user, injury, or delay in patient results.

• Brand Name: STATSPIN MP
• Type of Device: STATSPIN CENTRIFUGE
• Manufacturer (Section D): IRIS INTERNATIONAL; 9172 eton ave.; chatsworth CA 91311
• Manufacturer Contact: sudha gupta ; 9172 eton ave.; chatsworth, CA 91311 ; 8185277272
• MDR Report Key: 4307595
• MDR Text Key: 5194731
• Report Number: 2023446-2014-00179
• 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: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/06/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: X00-003917-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• 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