MAUDE Adverse Event Report: DUTCH OPTHALMIC RESEARCH CENTER BV EVA, COMBINED MACHINE INCLUDING LASER

Model Number	8000.COM03
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/05/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation determined a defective rotor.Our r&d department is currently trying to resolve these issues.During the retrospective review, and as per the complaint description, pump showed error pum152 and replacing the same will result in major delay of therapy and hence this is determined to be reportable.This reportable event was identified during a voluntary retrospective review of all complaints since 2015 by the manufacturer (dutch ophthalmic research centre (b)(4)).Details of this activity were discussed with cdrh office of compliance ((b)(6)) during a tele-conference on (b)(4) 2017.All available information has been disclosed.This complaint has now been closed.
Event or Problem Description
Error: pum152.Temperature error, motor broken.All information has been disclosed.

• Brand Name: EVA, COMBINED MACHINE INCLUDING LASER
• Common Device Name: EVA, COMBINED MACHINE INCLUDING LASER
• Manufacturer (Section D): DUTCH OPTHALMIC RESEARCH CENTER BV; scheijdelveweg 2; zuidland, 3214V N; NL 3214VN
• MDR Report Key: 7515727
• Report Number: 1222074-2018-00131
• Device Sequence Number: 19188803
• Product Code: HQC
• UDI-Device Identifier: 08717872019666
• UDI-Public: 08717872019666
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K142877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 10/05/2015

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: Physician
• Device Model Number: 8000.COM03
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2015
• Initial Report FDA Received Date: 05/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1