MAUDE Adverse Event Report: ANDREAS HETTICH GMBH & CO. KG HETTICH ROTINA 380 CENTRIFUGE; CENTRIFUGE HETTICH 380 110V

Catalog Number 490663

Device Problem Component Falling (1105)

Patient Problem Loss of consciousness (2418)

Event Date 07/20/2017

Event Type  Injury  

Manufacturer Narrative

The operator¿s manual states, the hettich rotina 380 centrifuge was designed for the separation of materials or mixtures.In particular, these include samples for preparation of in-vitro diagnostic purposes in human medicine.Bd quality noted this complaint was issued against the hettich rotina 380 centrifuge model which contains black shocks.In 2015, the (b)(4) supplier made a design change to make the lid mechanism more robust.New white springs are now used in the new centrifuges.Black hydraulic shock centrifuges are to be replaced upon failure.Root cause is attributed to wear of hydraulic gas springs causing the lid to free fall.Quality will continue to monitor trends.Device evaluated.

Event Description

Customer reports the lid of centrifuge fell down on her arm, causing the customer to "pass out" and hit her head on the cabinets behind her.The customer was treated in the er and received a cat scan which was negative.No further information has been provided regarding the customers treatment.

• Brand Name: HETTICH ROTINA 380 CENTRIFUGE
• Type of Device: CENTRIFUGE HETTICH 380 110V
• Manufacturer (Section D): ANDREAS HETTICH GMBH & CO. KG; tuttlingen D-785 32; GM D-78532
• Manufacturer (Section G): ANDREAS HETTICH GMBH & CO. KG; tuttlingen D-785 32; GM D-78532
• Manufacturer Contact: carol nieto ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 6784291
• MDR Text Key: 82416478
• Report Number: 1119779-2017-00006
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/09/2017

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 490663
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2017
• Initial Date FDA Received: 08/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2010
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention