MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-03 for VIP SWAN 0840619 manufactured by Icu Medical, Inc.
[177373542]
Upon needing a right heart catheter, the vip swan was prepped in normal fashion. While checking the integrity of the balloon via inflation of the balloon with the supplied 3 ml syringe, it would not inflate much at all. It was tried several times to get it to inflate, but it didn't have much integrity. Another balloon was used and worked fine (lot # 4145480 new device).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9659312 |
| MDR Report Key | 9659312 |
| Date Received | 2020-02-03 |
| Date of Report | 2019-10-18 |
| Date of Event | 2019-10-08 |
| Report Date | 2019-10-25 |
| Date Reported to FDA | 2019-10-25 |
| Date Reported to Mfgr | 2020-02-03 |
| Date Added to Maude | 2020-02-03 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIP SWAN |
| Generic Name | CATHETER, FLOW DIRECTED |
| Product Code | DYG |
| Date Received | 2020-02-03 |
| Model Number | 0840619 |
| Lot Number | 4123595 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ICU MEDICAL, INC |
| Manufacturer Address | 4455 ATHERTON DR SALT LAKE CITY UT 84123 US 84123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-03 |