MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2015-12-09 for NEOPIP NEONATAL T-PIECE CIRCUIT W/PEEP NF-150 manufactured by Neoforce Inc..
[34071143]
Hospital had 2 lots of inventory lot #'s 1140919005 and 1150430061. Devices from each lot were pulled from inventory and tested to attempt to replicate the failure mode. Simulated handling and moving circuit on bed surface according to customer complaint to see if high pressures are generated by the peep valve at the flow conditions and adjusting flow rate during use (contraindicated) we could not replicate device failure mode. Tested devices met specification and did not exceed pressure limits. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[34071144]
Hospital reported that while using a neopuff (fisher and paykel) infant resuscitator in conjunction with our neopip t-piece circuit (neoforce inc. ) that "there was a recent event during a preemie resuscitation where it was noted that all of a sudden a very high level of peep was being delivered (inadvertently) which resulted in a pneumothorax needing needle decompression in the dr (delivery room). Further: "in this particular incident the circuit had changed hands several times from the therapist to the nurse to the doctor back to the therapist so it could have been bumped in transition. " hospital says it has happened before but not to this degree and they felt that the circuit can be adjusted too easily.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005599562-2015-00001 |
| MDR Report Key | 5313421 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2015-12-09 |
| Date of Report | 2015-11-20 |
| Date of Event | 2015-10-14 |
| Date Mfgr Received | 2015-10-20 |
| Device Manufacturer Date | 2015-01-01 |
| Date Added to Maude | 2015-12-21 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | OTHO BOONE |
| Manufacturer Street | 35 COMMERCE DR. |
| Manufacturer City | IVYLAND PA 18974 |
| Manufacturer Country | US |
| Manufacturer Postal | 18974 |
| Manufacturer Phone | 2156726800 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NEOPIP NEONATAL T-PIECE CIRCUIT W/PEEP |
| Generic Name | ATTACHMENT, BREATHING, PEEP |
| Product Code | BYE |
| Date Received | 2015-12-09 |
| Model Number | NF-150 |
| Lot Number | 1140919005 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEOFORCE INC. |
| Manufacturer Address | 35 COMMERCE DR. IVYLAND PA 18974 US 18974 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-12-09 |