MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-24 for PNEUPAC? PATIENT CIRCUIT KITS 100/905/340 manufactured by Smiths Medical Asd; Inc..
[124966452]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[124966453]
Information was received indicating that a patient with a smiths medical pneupac? Patient circuit was unable to be ventilated. The air circuit was then changed out; solving the problem. The following day the expiratory valve was noted to be "strange," causing leakage of gas. There were no reported adverse patient effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2018-01856 |
| MDR Report Key | 8000510 |
| Date Received | 2018-10-24 |
| Date of Report | 2018-10-24 |
| Date of Event | 2018-09-21 |
| Date Mfgr Received | 2018-09-25 |
| Device Manufacturer Date | 2018-06-01 |
| Date Added to Maude | 2018-10-24 |
| 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 | DAVE HALVERSON |
| Manufacturer Street | 6000 NATHAN LANE N |
| Manufacturer City | MINNEAPOLIS, MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833310 |
| Manufacturer G1 | SMITHS MEDICAL INTERNATIONAL LTD |
| Manufacturer Street | BRAMINGHAM BUSINESS PARK ENTERPRISE WAY |
| Manufacturer City | LUTON, BEDS LU3 4BU |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LU3 4BU |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PNEUPAC? PATIENT CIRCUIT KITS |
| Generic Name | ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE |
| Product Code | BYE |
| Date Received | 2018-10-24 |
| Returned To Mfg | 2018-09-28 |
| Catalog Number | 100/905/340 |
| Lot Number | 180328 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD; INC. |
| Manufacturer Address | 6000 NATHAN LANE N MINNEAPOLIS, MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-24 |