MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-06-11 for RESMED CPAP: S8 AUTO SET II H4I manufactured by Resmed Corp.
[1342610]
Cpap type medical equipment with heated humidifiers lack, automatic safety shut-off, possibly general condition in cpap industry. Regular heated humidifiers, -non-medical equipment-, have an automatic safety shut-off. Consequences if cpap unit runs out of water, pt becomes unconscious, or if the unit turns over with water in it? Pt is attached directly to the cpap equipment by a heated-humidified-air hose while sleeping and possibly tossing and turning, even greater potential for an equipment tip-over and possibility for short circuit, fire, burns, or electrocution. Because of medical/sleep issues, the pt may be even more vulnerable to catastrophic consequences in the event of a cpap accident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5016357 |
| MDR Report Key | 1726758 |
| Date Received | 2010-06-11 |
| Date of Report | 2010-06-11 |
| Date Added to Maude | 2010-06-21 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESMED CPAP: S8 AUTO SET II H4I |
| Generic Name | CPAP |
| Product Code | NHJ |
| Date Received | 2010-06-11 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESMED CORP |
| Manufacturer Address | 9001 SPECTRUM CENTER BLVD SAN DIEGO CA 92123 US 92123 |
| Brand Name | RESMED CPAP: S9 H5I |
| Generic Name | CPAP |
| Product Code | NHJ |
| Date Received | 2010-06-11 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | RESMED CORP |
| Manufacturer Address | 9001 SPECTRUM CENTER BLVD SAN DIEGO CA 92123 US 92123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-06-11 |