MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-02-20 for NEOPUFF INFANT RESUSCITATOR 900IW130 manufactured by Fisher & Paykel Healthcare Limited.
[183968605]
(b)(4). Method: the complaint 900iw130 neopuff infant resuscitator was not returned to fisher & paykel healthcare for evaluation. Our investigation is based on the photography provided by the customer and our knowledge of the product. Results: visual inspection of the photography revealed that the adjustment knob was broken. Conclusion: the neopuff is a portable, reusable device used to assist in the delivery of respiratory breaths to infant until adequate spontaneous breathing occurs. Being a portable device, the neopuff can be susceptible to damage, for instance when accidentally dropped or subjected to considerable external force. The neopuff technical manual states the following: dropping the neopuff infant resuscitator or other similar forms of impact may cause damage resulting in incorrect operation of the unit. If you suspect damage to have occurred, please perform checks as outlined [in the manual] before connection to a patient. In addition, the neopuff user instructions state that the user should "check manometer reads zero with no gas flow" and check the pressure settings "prior to every use of the neopuff". Each neopuff unit is assembled and 100% tested in the production line to verify that each unit conforms to critical product specifications. Any unit that fails is rejected.
Patient Sequence No: 1, Text Type: N, H10
[183968606]
A healthcare facility in (b)(6) reported that the adjustment knob for the peak inspiratory pressure (pip) valve of a 900iw130 neopuff infant resuscitator is broken. There was no reported patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2020-00186 |
| MDR Report Key | 9736283 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-02-20 |
| Date of Report | 2020-01-22 |
| Date Mfgr Received | 2020-01-22 |
| Device Manufacturer Date | 2010-09-09 |
| Date Added to Maude | 2020-02-20 |
| 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 | MS. FARANAK GOMAROONI |
| Manufacturer Street | 173 TECHNOLOGY DR., SUITE 100 IRVINE |
| Manufacturer City | CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9494534000 |
| Manufacturer G1 | FISHER & PAYKEL HEALTHCARE LIMITED |
| Manufacturer Street | 15 MAURICE PAYKEL PLACE EAST TAMAKI |
| Manufacturer City | AUCKLAND, 2013 |
| Manufacturer Country | NZ |
| Manufacturer Postal Code | 2013 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEOPUFF INFANT RESUSCITATOR |
| Generic Name | BTL |
| Product Code | BTL |
| Date Received | 2020-02-20 |
| Model Number | 900IW130 |
| Catalog Number | 900IW130 |
| Lot Number | 040308 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FISHER & PAYKEL HEALTHCARE LIMITED |
| Manufacturer Address | 15 MAURICE PAYKEL PLACE EAST TAMAKI AUCKLAND, 2013 NZ 2013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-20 |