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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SITE~RITE 8 ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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SITE~RITE 8 ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Catalog Number 9770550
Device Problems Crack (1135); Material Separation (1562); Defective Component (2292); Charging Problem (2892); Unexpected Shutdown (4019)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/18/2020
Event Type  malfunction  
Manufacturer Narrative
The device has not been received by the manufacturer for evaluation.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
 
Event Description
The machine is not charging, if it turns on it switches off soon afterwards, plastic and area around site rite has many cracks, probe rubber has come off, cord looks damaged machine not working, not sure if charger is working.Touch screen to be checked.
 
Event Description
The machine is not charging, if it turns on it switches off soon afterwards, plastic and area around site rite has many cracks, probe rubber has come off, cord looks damaged machine not working, not sure if charger is working.Touch screen to be checked.
 
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 abrupt shutdown was confirmed.The unit is not charging and the charging port is intermittent.The root cause of the failure was identified as use-related failure of the motherboard and battery.
 
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Brand Name
SITE~RITE 8 ULTRASOUND SYSTEM
Type of Device
SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
MDR Report Key10669595
MDR Text Key212525954
Report Number3006260740-2020-20069
Device Sequence Number1
Product Code IYO
UDI-Device Identifier00801741098208
UDI-Public(01)00801741098208
Combination Product (y/n)N
PMA/PMN Number
K152554
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Remedial Action Notification
Type of Report Initial,Followup
Report Date 10/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number9770550
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/09/2021
Date Manufacturer Received10/14/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction Number2243072-10/11/2019-013-C
Patient Sequence Number1
Patient Outcome(s) Other;
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