MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-02 for DAR 331/5661 manufactured by Mallinckrodt Dar Srl.
[116051818]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[116051819]
According to the reporter, the unit had leaks. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[131529662]
Evaluation summary: one sample was received for evaluation. The sample was visually inspected and resulted to be severely used, but no damages were identified. Information has been added to the database and trends will continue to be monitored. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[131529663]
According to the reporter, the unit had leaks. When the ventilator was connected, the alarm was continued. After the connection tube was replaced, the alarm sound was released. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[132439751]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936999-2018-00481 |
| MDR Report Key | 7742107 |
| Date Received | 2018-08-02 |
| Date of Report | 2018-12-03 |
| Date of Event | 2018-07-18 |
| Date Mfgr Received | 2018-11-09 |
| Device Manufacturer Date | 2017-05-29 |
| Date Added to Maude | 2018-08-02 |
| 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 | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| 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 | 0 |
| Brand Name | DAR |
| Generic Name | CONNECTOR, AIRWAY (EXTENSION) |
| Product Code | BZA |
| Date Received | 2018-08-02 |
| Returned To Mfg | 2018-10-31 |
| Model Number | 331/5661 |
| Catalog Number | 331/5661 |
| Lot Number | 17E1241FAX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-08-02 |