MAUDE Adverse Event Report: REFURB, SITE-RITE 8; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Catalog Number	9770501R
Medical Device Problem Code	Data Problem (3196)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
Event or Problem Description
Per biomed, battery light is flashing when plugged in.Status of battery indicates either 8 or 73% whether plugged or unplugged.
Additional Manufacturer Narrative
H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the device was returned to the service facility for evaluation.During evaluation, the reported issue of battery health was confirmed.The site rite 8 was visually inspected upon receipt and was found to be in good physical condition.The reported issue is confirmed; the battery cycle count is at 209 and also showing the battery health has degraded message.Initially powering the unit on had the battery icon showing red which is the switch on the back has been turned off to preserve the battery.When scanner is powered off and charging, the battery icon will flash green stating it is charging the battery.The root cause of the reported issue is an internal li-ion battery failure.A history review of serial number (b)(6) showed no other similar product complaint(s) from this serial number.
Event or Problem Description
Per biomed, battery light is flashing when plugged in.Status of battery indicates either 8 or 73% whether plugged or unplugged.

• Brand Name: REFURB, SITE-RITE 8
• Common Device Name: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• MDR Report Key: 10431234
• Report Number: 3006260740-2020-02957
• Device Sequence Number: 19567997
• Product Code: IYO
• UDI-Device Identifier: 10801741104135
• UDI-Public: (01)10801741104135
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K152554
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2020

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: Health Professional
• Device Catalogue Number: 9770501R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 11/15/2020
• Initial Report FDA Received Date: 08/20/2020
• Supplement Report FDA Received Date: 11/30/2020
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1