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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SITE~RITE PREVUE SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

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C.R. BARD, INC. (BASD) -3006260740 SITE~RITE PREVUE SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Catalog Number 9770239
Device Problems Failure to Charge (1085); Unexpected Shutdown (4019)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/18/2021
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 equipment is heating up a lot, even when it is turned off, when it is being charged with energy.And in use, it shows that the device's battery is half full, the symbol for turning the device off appears on the screen.
 
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 system overheating was confirmed.It was identified that the battery must be replaced.This is the root cause of the heating.A history review of serial number (b)(6) showed no other similar product complaint(s) from this serial number.
 
Event Description
The equipment is heating up a lot, even when it is turned off, when it is being charged with energy.And in use, it shows that the device's battery is half full, the symbol for turning the device off appears on the screen.
 
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Brand Name
SITE~RITE PREVUE SYSTEM
Type of Device
SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
MDR Report Key11642118
MDR Text Key244890908
Report Number3006260740-2021-01231
Device Sequence Number1
Product Code IYO
Combination Product (y/n)N
PMA/PMN Number
K150529
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 07/14/2021
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
Device Operator Health Professional
Device Catalogue Number9770239
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/28/2021
Initial Date Manufacturer Received 03/18/2021
Initial Date FDA Received04/09/2021
Supplement Dates Manufacturer Received07/14/2021
Supplement Dates FDA Received07/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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