MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-07 for CAPNOSTREAM 20 CS08651-01 manufactured by Oridion-rx.
[40043442]
(b)(4). Root cause identified as workmanship issues during battery pack assembly, coupled with shock and vibration during transit. Process improvements and additional production controls were implemented at the battery pack manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[40043443]
Medtronic received a report that while unpacking the box, prior to installation, it was noted that the battery appeared to have "burn marks". There was no end patient involvement or harm to the users.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8044004-2016-00005 |
| MDR Report Key | 5485005 |
| Date Received | 2016-03-07 |
| Date of Report | 2016-03-03 |
| Date of Event | 2014-10-23 |
| Date Mfgr Received | 2014-10-23 |
| Device Manufacturer Date | 2014-08-01 |
| Date Added to Maude | 2016-03-07 |
| 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 | 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 |
| Generic Name | BEDSIDE CAPNOGRAPH/PULSE OXIMETER |
| Product Code | MNR |
| Date Received | 2016-03-07 |
| Returned To Mfg | 2014-10-27 |
| Model Number | CS08651-01 |
| Catalog Number | CS08651-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORIDION-RX |
| Manufacturer Address | ORIDION MEDICAL LTD P O BOX 45025 JERUSULEM IS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-07 |