MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-11-19 for ONE-WAY VALVE 1644 manufactured by Hudson Respiratory Care, Inc..
[313436]
In october 2004, hudson rci was contacted by an contact representing a patient who had died while receiving an mri and being manually resuscitated. The contact indicated that the patient death was due to an incorrect set-up of equipment by the facility. Photos of the actual set-up used by the facility that contributed to the death, and photos of the set-up as the facility indicated it should have been created were provided to hudson rci. It was reported that the facility had claimed responsibility for the death. The hudson rci device worked as designed, and was properly installed in the configuration used at the time of death, as determined by the photos provided. No sample will be submitted for evaluation. No further investigation is required of hudson rci.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2014730-2004-00011 |
| MDR Report Key | 556218 |
| Report Source | 05 |
| Date Received | 2004-11-19 |
| Date Mfgr Received | 2004-10-20 |
| Date Added to Maude | 2004-11-24 |
| 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 | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DAN DAILY |
| Manufacturer Street | 27711 DIAZ ROAD |
| Manufacturer City | TEMECULA CA 92580 |
| Manufacturer Country | US |
| Manufacturer Postal | 92580 |
| Manufacturer Phone | 9516765611 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ONE-WAY VALVE |
| Generic Name | ONE-WAY VALVE |
| Product Code | CBP |
| Date Received | 2004-11-19 |
| Model Number | NA |
| Catalog Number | 1644 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 545890 |
| Manufacturer | HUDSON RESPIRATORY CARE, INC. |
| Manufacturer Address | 27711 DIAZ RD. TEMECULA CA 92590 US |
| Baseline Brand Name | ONE-WAY VALVE |
| Baseline Generic Name | ONE-WAY VALVE |
| Baseline Model No | NA |
| Baseline Catalog No | 1644 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2004-11-19 |