MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-10-10 for PRESSURE ALARM 23001 manufactured by Respironics Inc..
[3066905]
The mfr received info alleging an external pressure alarm was not working properly when connected to a ventilator. There was no report of pt harm or injury.
Patient Sequence No: 1, Text Type: D, B5
[10278353]
The device was evaluated by the mfr. The mfr found the battery connector was damaged. The device would not work on battery power but would operate as designed on ac power. A failure of the external pressure alarm would not affect any connected device's primary alarms or function. The connected device (the ventilator) would continue to provide therapy and audibly alarm as designed. Awaiting estimate approval from customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2518422-2012-02098 |
| MDR Report Key | 2785266 |
| Report Source | 06 |
| Date Received | 2012-10-10 |
| Date of Report | 2012-09-19 |
| Date of Event | 2012-09-19 |
| Date Mfgr Received | 2012-09-19 |
| Device Manufacturer Date | 2005-02-01 |
| Date Added to Maude | 2012-12-31 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DON MCANDREWS |
| Manufacturer Street | 1740 GOLDEN MILE HIGHWAY |
| Manufacturer City | MONROEVILLE PA 15146 |
| Manufacturer Country | US |
| Manufacturer Postal | 15146 |
| Manufacturer Phone | 7243873965 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRESSURE ALARM |
| Generic Name | VENTILATOR, CONTINUOUS, FACILITY USE |
| Product Code | CAP |
| Date Received | 2012-10-10 |
| Returned To Mfg | 2012-09-25 |
| Model Number | 23001 |
| Catalog Number | 23001 |
| Lot Number | 23001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESPIRONICS INC. |
| Manufacturer Address | MURRYSVILLE PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-10 |