MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,user facility report with the FDA on 2015-07-22 for HUDSON DISP MANUAL RESUS,ADULT W/FLOW DIVERTER 5372 manufactured by Teleflex Medical.
[6055250]
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
[13512660]
(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
[24808221]
(b)(4). The sample was returned for evaluation. A visual exam was performed and it was observed that the hard shell of the mask was deformed and the air cushion was deflated. The air cushion was filled with gas and then submerged in water and the air cushion was pressed by hand. No any bubbles (or leakages) were found. Based on the investigation performed, the reported complaint was confirmed. The mask was manufactured in 2011 and the expiration date was 2014. It was determined that the air leaked naturally during the long time in storage, which caused the deformation of the mask.
Patient Sequence No: 1, Text Type: N, H10
[24808222]
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
| Report Number | 1044475-2015-00242 |
| MDR Report Key | 4932533 |
| Report Source | 06,USER FACILITY |
| Date Received | 2015-07-22 |
| Date of Report | 2015-06-30 |
| Date of Event | 2015-04-27 |
| Date Mfgr Received | 2015-08-25 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KATHARINE TARPLEY |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334854 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | 2917 WECK DRIVE |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27709 |
| 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 | 1146 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-22 |