MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-11-12 for DAR 352U5805 manufactured by Mallinckrodt Dar Srl.
[166127865]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[166127866]
According to the reporter, during use, the pediatric patients had been brought in to the intensive care unit with hypoxia and hypercarbia. The physician stated that the filter and vent circuits that were being used was not the correct sizes. It was indicated that they are using a filter adult/pediatrics large for all populations.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2019-00937 |
| MDR Report Key | 9313479 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-11-12 |
| Date of Report | 2019-11-12 |
| Date of Event | 2019-10-25 |
| Date Mfgr Received | 2019-10-28 |
| Date Added to Maude | 2019-11-12 |
| 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 | AVI KLUGER |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 3035306582 |
| Manufacturer G1 | MALLINCKRODT DAR SRL |
| Manufacturer Street | VIA GIACOMO BOVE 2/4/6/8 |
| Manufacturer City | MIRANDOLA 41037 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 41037 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DAR |
| Generic Name | FILTER, BACTERIAL, BREATHING-CIRCUIT |
| Product Code | CAH |
| Date Received | 2019-11-12 |
| Model Number | 352U5805 |
| Catalog Number | 352U5805 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MALLINCKRODT DAR SRL |
| Manufacturer Address | VIA GIACOMO BOVE 2/4/6/8 MIRANDOLA 41037 IT 41037 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-11-12 |