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	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Our distributor has requested the return of the malfunctioning centrifuge, but they have not yet received it back from their customer.We have examined photos of the failed unit.It appears that the hematocrit rotor broke, causing the unit to become imbalanced and to then come apart and eject pieces of plastic.In conjunction with our distributor, we will continue the investigation once the unit is returned.In the meantime, we have initiated a recall of the product containing this rotor.
Event or Problem Description
A user of the centrifuge was injured when the centrifuge malfunctioned and broke apart.Pieces of plastic struck the technician.She was treated at the emergency room and released.She required stitches in her arm and had some bruising on her chest/abdomen.
Additional Manufacturer Narrative
Note: this is resubmission of report #3011816315-2019-00001.The original submission was erroneously marked as a 5-day report.It should be a 30-day report, as our organization was not required to initiate action to prevent an unreasonable risk of substantial harm.

• 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, zhejiang 31700 0; CH 317000
• MDR Report Key: 8771348
• Report Number: 3011816315-2019-00001
• Device Sequence Number: 14027596
• 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: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2019

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
• Operator of Device: Other
• Device Model Number: HW24H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2019
• Supplement Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 07/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other