MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-07-22 for HUDSON DISP MANUAL RESUS,ADULT W/FLOW DIVERTER 5372 manufactured by .
[22240679]
The customer alleges that the mask was found deflated on the crash cart. No patient injury or involvement.
Patient Sequence No: 1, Text Type: D, B5
[22319001]
(b)(4). The device sample was received by the manufacturer, but the investigation is incomplete at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1044475-2015-00250 |
| MDR Report Key | 4932400 |
| Report Source | 06 |
| Date Received | 2015-07-22 |
| Date of Report | 2015-06-30 |
| Date of Event | 2015-04-27 |
| Date Mfgr Received | 2015-06-30 |
| Date Added to Maude | 2015-07-22 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARGIE BURTON, RN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334965 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON DISP MANUAL RESUS,ADULT W/FLOW DIVERTER |
| Generic Name | ADULT RESUSCITATION BAG |
| Product Code | NHK |
| Date Received | 2015-07-22 |
| Returned To Mfg | 2015-07-08 |
| Catalog Number | 5372 |
| Lot Number | 1336 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-22 |