MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-04 for PREMIER PRO 8801 manufactured by S2s Global.
[74515308]
Patient Sequence No: 1, Text Type: N, H10
[74515309]
1. Pressure bags over inflate (after they are hanging for a while) and cause the fluid bag to rupture and spray/leak. 2. Premier pro 1 liter pressure bags (reorder number (b)(4)) do not encompass the entire liter bag of saline. When pumped up to 300 mmhg, the saline bags are bursting. 3. The pressure gauge often did not engage until the bag was filled/overfilled and then would pop out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6546073 |
| MDR Report Key | 6546073 |
| Date Received | 2017-05-04 |
| Date of Report | 2017-04-11 |
| Date of Event | 2017-04-03 |
| Report Date | 2017-03-29 |
| Date Reported to FDA | 2017-03-29 |
| Date Reported to Mfgr | 2017-03-29 |
| Date Added to Maude | 2017-05-04 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | 0 |
| Brand Name | PREMIER PRO |
| Generic Name | INFUSOR, PRESSURE, FOR I.V. BAGS |
| Product Code | KZD |
| Date Received | 2017-05-04 |
| Returned To Mfg | 2017-04-05 |
| Model Number | 8801 |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | S2S GLOBAL |
| Manufacturer Address | 14120 BALLANTYNE CORPORATE PLACE SUITE 425 CHARLOTTE NC 28277 US 28277 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-04 |