BARD ACCESS SYSTEMS SITE~RITE 8 ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
|
Back to Search Results |
|
Catalog Number 9770550 |
Device Problems
Battery Problem (2885); Power Problem (3010)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
Manufacturer Narrative
|
The device has not been received by the manufacturer for evaluation.A lot history review (lhr) review is not possible, as the device is manufactured using a unique serial number and not by lot number.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
|
|
Event Description
|
It was reported that there is not power enough to keep the system on, even though the battery is at 65%.
|
|
Event Description
|
It was reported that there is not power enough to keep the system on, even though the battery is at 65%.
|
|
Manufacturer Narrative
|
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 shutdown during use was confirmed.The system was found to shutdown unexpectedly due to a faulty battery.The device will be serviced, tested, and returned to the customer.A lot history review (lhr) review is not possible, as the device is manufactured using a unique serial number and not by lot number.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
|
|
Event Description
|
It was reported that there is not power enough to keep the system on, even though the battery is at 65%.
|
|
Manufacturer Narrative
|
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 shutdown during use was confirmed.The system was found to shutdown unexpectedly due to a faulty battery.The device will be serviced, tested, and returned to the customer.A lot history review (lhr) review is not possible, as the device is manufactured using a unique serial number and not by lot number.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
|
|
Search Alerts/Recalls
|
|
|