MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-04-10 for PNEUPAC? SINGLE USE PATIENT CIRCUIT KITS 100/905/320 manufactured by Smiths Medical Asd, Inc..
[72298625]
Customer has not yet returned the device to the manufacturer for device evaluation. When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation. Patient's age was not provided; however. It was reported that the patient was a "baby" it was reported that the event occurred in (b)(6) 2017; however, the exact date was not provided.
Patient Sequence No: 1, Text Type: N, H10
[72298626]
It was reported that immediately upon patient use of the babypac ventilator it was observed that the disposable pneupac? Single use patient circuit had two splits down the side of the plastic. It was further reported that the tubing broke apart at the "22f connector ventilator end". The observed issue resulted in the patient not being ventilated properly for a short period of time. According to the report, medical intervention was needed and a neopuff? Was used to deliver the required pressure to the patient. The reported incident was observed immediately upon patient use. No permanent adverse effects to patient reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2017-00817 |
| MDR Report Key | 6477697 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-04-10 |
| Date of Report | 2017-04-10 |
| Date Mfgr Received | 2017-03-17 |
| Device Manufacturer Date | 2016-09-02 |
| Date Added to Maude | 2017-04-10 |
| 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 | LISA PERZ |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833074 |
| Manufacturer G1 | SMITHS MEDICAL INTERNATIONAL NIJMEGEN |
| Manufacturer Street | BIJSTERHUIZEN 22 - 08 |
| Manufacturer City | WIJCHEN, LD 6604 |
| Manufacturer Country | NL |
| Manufacturer Postal Code | 6604 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PNEUPAC? SINGLE USE PATIENT CIRCUIT KITS |
| Generic Name | ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE |
| Product Code | BYE |
| Date Received | 2017-04-10 |
| Catalog Number | 100/905/320 |
| Lot Number | 160704 |
| Device Expiration Date | 2019-07-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-04-10 |