MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-05-01 for OWENS AND MINOR 950206600 manufactured by Ventlab.
[107498180]
The customer returned the affected product and the customer complaint was confirmed. Current inventory is not exhibiting any failure modes of reported claim in the field.
Patient Sequence No: 1, Text Type: N, H10
[107498181]
The customer alleges that " infuser bag is losing pressure. " no other details were provided and no patient injury/harm reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1314417-2018-00002 |
| MDR Report Key | 7477476 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-05-01 |
| Date of Report | 2018-05-01 |
| Date of Event | 2018-02-01 |
| Date Added to Maude | 2018-05-01 |
| 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 | MS. CARRIE FORTUNA |
| Manufacturer Street | 2710 NORTHRIDGE DR. SUITE A |
| Manufacturer City | GRAND RAPIDS MI 49544 |
| Manufacturer Country | US |
| Manufacturer Postal | 49544 |
| Manufacturer Phone | 6162598400 |
| Manufacturer G1 | VENTLAB |
| Manufacturer Street | 2710 NORTHRIDGE DR. SUITE A |
| Manufacturer City | GRAND RAPIDS MI 49544 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49544 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OWENS AND MINOR |
| Generic Name | PRESSURE INFUSER BAG |
| Product Code | KZD |
| Date Received | 2018-05-01 |
| Returned To Mfg | 2018-04-25 |
| Model Number | 950206600 |
| Lot Number | 170300148 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VENTLAB |
| Manufacturer Address | 2710 NORTHRIDGE DR. SUITE A GRAND RAPIDS MI 49544 US 49544 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-01 |