MAUDE Adverse Event Report: ZHEJIANG HUAWEI SCIENTIFIC INSTRUMENT CO LTD LW SCIENTIFIC ZIP-IQ PCV CENTRIFUGE; TABLETOP HEMATOCRIT CENTRIFUGE

Model Number	HW24H
Medical Device Problem Code	Misassembly by Users (3133)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our distributor has evaluated the returned unit.Per photos and explanation provided by the user and evaluation of the returned unit, it appears that the centrifuge rotor was not properly tightened down.This allowed the rotor and rotor top to move up the rotor shaft.This caused friction so that the unit did not reach the set speed; therefore, the timer did not count down and the unit continued to run.The wobble created by the improperly installed rotor then caused an imbalance that led to the rotor breaking and compromising the centrifuge housing.The operations manual provided by the distributor clearly states that the rotor must be tightened with a wrench, but the rotor was not tightened when they received the unit back.The behavior of the centrifuge is also indicative of the rotor not being properly installed.
Event or Problem Description
The centrifuge timer did not count down, and the unit continued to run past the set time.The centrifuge then broke apart.Pieces of plastic struck the technician.The technician sustained minor injuries and did not seek medical attention.

• Brand Name: LW SCIENTIFIC ZIP-IQ PCV CENTRIFUGE
• Common Device Name: TABLETOP HEMATOCRIT CENTRIFUGE
• Manufacturer (Section D): ZHEJIANG HUAWEI SCIENTIFIC INSTRUMENT CO LTD; 237 zhangyang road; linhai, 31700 0; CH 317000
• MDR Report Key: 8744322
• Report Number: 3011816315-2019-00004
• Device Sequence Number: 16654018
• Product Code: GKG
• UDI-Device Identifier: 00664816002629
• UDI-Public: 00664816002629
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/24/2019

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?: Yes
• Operator of Device: Other
• Device Model Number: HW24H
• Was Device Available for Evaluation?: No
• Device Age: 14 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1