MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-08 for CAPNOSTREAM 20 (US) N W/PRINTER CS08657 manufactured by Oridion.
[33437801]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
[33437802]
During routine maintenance of the unit it was observed that there was no speaker audio. There was no patient involved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8044004-2015-00010 |
| MDR Report Key | 5275421 |
| Date Received | 2015-12-08 |
| Date of Report | 2015-11-13 |
| Date Mfgr Received | 2015-11-13 |
| Device Manufacturer Date | 2013-08-01 |
| Date Added to Maude | 2015-12-08 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | THOM MCNAMARA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524811 |
| Manufacturer G1 | ORIDION-RX |
| Manufacturer Street | ORIDION MEDICAL LTD P O BOX 45025 |
| Manufacturer City | JERUSULEM |
| Manufacturer Country | IS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CAPNOSTREAM 20 (US) N W/PRINTER |
| Generic Name | PORTABLE BEDSIDE CAPNOGRAPH/PULSE OXIMETER |
| Product Code | MNR |
| Date Received | 2015-12-08 |
| Model Number | CS08657 |
| Catalog Number | CS08657 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORIDION |
| Manufacturer Address | ORIDION MEDICAL LTD P O BOX 45025 JERUSULEM IS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-08 |