MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SITE-RITE 8 ULTRASOUND; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number 9770501

Device Problems Application Program Problem (2880); No Apparent Adverse Event (3189); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/13/2021

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 one similar complaint from this serial number.The similar complaints have been reported by the same us facility.The previous complaint evaluations for this serial number (b)(4) are: inconclusive, no sample returned for evaluation.(reference: mdr number 3006260740-2020-20059).

Event Description

Hold for ab 2.22 per biomed - this unit is still freezing up and displaying the ec111 error intermittently.

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 overheating, ec111 error, and system freezing was unconfirmed.The scanner was powered on and ran for 24 hours.During the entire duration, it never froze and the back of the unit was warm, but not abnormally hot to touch.The root cause of the reported failure is inconclusive as the reported issue could not be reproduced during evaluation.A history review of serial number dybnac060 showed one similar complaint from this serial number.The similar complaints have been reported by the same us facility.The previous complaint evaluations for this serial number (dybnac060) are: inconclusive, no sample returned for evaluation.(reference: mdr number 3006260740-2020-20059).

Event Description

Per biomed - this unit is still freezing up and displaying the ec111 error intermittently.

• Brand Name: SITE-RITE 8 ULTRASOUND
• 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 Key: 11313360
• MDR Text Key: 232850893
• Report Number: 3006260740-2021-00309
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741098338
• UDI-Public: (01)00801741098338
• Combination Product (y/n): N
• PMA/PMN Number: K152554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/07/2021

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 Model Number: 9770501
• Device Catalogue Number: 9770501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 02/11/2021
• Supplement Dates Manufacturer Received: 05/07/2021
• Supplement Dates FDA Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other