MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-12-05 for PRESSURE ALARM 23001 manufactured by Respironics, Inc..
[20987733]
The manufacturer received information alleging a pressure alarm was not working properly when connected to a ventilator. There was no report of harm or injury.
Patient Sequence No: 1, Text Type: D, B5
[21307291]
The device was evaluated by the manufacturer. The manufacturer found the battery contacts to be broken not allowing the 9 volt battery to be inserted into the device. The device would not operate on battery power but would operate as designed on ac power. A failure of the 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2518422-2012-02411 |
| MDR Report Key | 2862196 |
| Report Source | 07 |
| Date Received | 2012-12-05 |
| Date of Report | 2012-11-13 |
| Date of Event | 2012-11-13 |
| Date Mfgr Received | 2012-11-13 |
| Device Manufacturer Date | 2007-01-01 |
| Date Added to Maude | 2013-01-02 |
| 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 MCANDRES |
| 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 | VENTILATORY, CONTINUOUS, FACILITY USE |
| Product Code | CAP |
| Date Received | 2012-12-05 |
| Returned To Mfg | 2012-11-20 |
| Model Number | 23001 |
| Catalog 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 | 2012-12-05 |