MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-30 for AC3 OPTIMUS IABP NA/EMEA IPN001112 IAP-0700 manufactured by Arrow International Inc..
[185515877]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185515878]
It was reported that when the hospital staff attempted to connect the fiberoptic iab to the autocat3 intra-aortic balloon pump (iabp), the staff only got the first green check mark on the checklist. The staff then switched to an autocat2 wave iabp and it worked appropriately, zeroed the fos and the patient is being supported on that pump. There was no report of patient complications, serious injury or death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010532612-2020-00084 |
| MDR Report Key | 9897399 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-03-13 |
| Date Mfgr Received | 2020-03-13 |
| Date Added to Maude | 2020-03-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JONATHAN KIMCHAN |
| Manufacturer Street | 16 ELIZABETH DRIVE |
| Manufacturer City | CHELMSFORD MA 01824 |
| Manufacturer Country | US |
| Manufacturer Postal | 01824 |
| Manufacturer G1 | ARROW INTERNATIONAL INC. |
| Manufacturer Street | 16 ELIZABETH DRIVE |
| Manufacturer City | CHELMSFORD MA 01824 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01824 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AC3 OPTIMUS IABP NA/EMEA |
| Generic Name | SYSTEM, BALLOON, INTRA-AORTIC |
| Product Code | DSP |
| Date Received | 2020-03-30 |
| Model Number | IPN001112 |
| Catalog Number | IAP-0700 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARROW INTERNATIONAL INC. |
| Manufacturer Address | READING PA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |