Catalog Number IAP-0500 |
Device Problem
Battery Problem (2885)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/27/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported via a field service report (b)(4).Symptom: pump giving 20 minute alarm after running for 30 minutes on battery.Per the hospital biomed the pump was switched off the patient quickly.Iap therapy was completed as planned.No patient complications or other intervention was required.Findings/action taken: batteries sent to and replaced by hospital biomed.Fcn level: (b)(4), software level: 2.24.
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Manufacturer Narrative
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(b)(4).Evaluation: teleflex received the affected batteries for analysis.They were tested using a known good autocat2w and a digital multi-meter amp2-154 was used and the battery load test was performed.The battery (l/n: 18f16c0033) passed the load test with no accuracy problems found.The battery (l/n: 18f15k0033) failed a battery load test.A careful visual inspection was also performed and no abnormalities were noted.The root cause of the premature battery failure is unknown.Teleflex assessed the risk for the reported complaint and determined that there are no new or revised risks.A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex will continue to monitor for similar reports of this issue.Other remarks: the reported complaint of the battery alarm was confirmed on one of the two returned batteries.No actions are planned at this time.
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Event Description
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It was reported via (b)(4).Symptom: pump giving 20 minute alarm after running for 30 minutes on battery.Per the hospital biomed the pump was switched off the patient quickly.Iap therapy was completed as planned.No patient complications or other intervention was required.Findings/action taken: batteries sent to and replaced by hospital biomed.Fcn level: 1416, software level: 2.24.
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Search Alerts/Recalls
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