BARD ACCESS SYSTEMS SITE-RITE 8 ULTRASOUND SYSTEM W/PINPOINT GT; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
|
Back to Search Results |
|
Model Number 9770501 |
Device Problems
Loss of Power (1475); Battery Problem (2885)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
Manufacturer Narrative
|
The information provided by bard 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 bard.The manufacturer has received the sample and will be evaluated.Results are expected soon.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.
|
|
Event Description
|
Customer reported unit shuts down when the battery is still at 80%.
|
|
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: during evaluation, the reported issue of abrupt shutdown during use was confirmed.The scanner was charged to 100% and when the ac adapter was removed, the scanner ran on battery power for less than 5 minutes.The root cause of the shutdown during use was identified as a failure in the lithium-ion battery.The review of the dhr, sub-assembly dhr, sub-assembly manufacturing, component records, manufacturing process changes, mrr/mrb, and internal rejects showed that the reported issue is not likely related to a manufacturing issue.No other issues with the equipment were found during evaluation.The sr8 was serviced, qc tested, and returned to the customer.
|
|
Event Description
|
Customer reported unit shuts down when the battery is still at 80%.
|
|
Event Description
|
Customer reported unit shuts down when the battery is still at 80%.
|
|
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: during evaluation, the reported issue of abrupt shutdown during use was confirmed.The scanner was charged to 100% and when the ac adapter was removed, the scanner ran on battery power for less than 5 minutes.The root cause of the shutdown during use was identified as a failure in the lithium-ion battery.The review of the dhr, sub-assembly dhr, sub-assembly manufacturing, component records, manufacturing process changes, mrr/mrb, and internal rejects showed that the reported issue is not likely related to a manufacturing issue.No other issues with the equipment were found during evaluation.The sr8 was serviced, qc tested, and returned to the customer.
|
|
Search Alerts/Recalls
|
|
|