MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2010-11-04 for N/A OM-9000S manufactured by Ascent.
[1736381]
It was reported that during a coronary bypass procedure the vacuum stabilizer's suction stopped working. Another device was retrieved to complete the procedure and no patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[8897116]
The complaint device was evaluated and it was found that dried adhesive was blocking the majority of the tubing connection hole contributing to the insufficient suction. A review of the device history record for the reported device indicated that the stabilizer passed all applicable tests and inspections prior to release. Ascent has procedures in place to prevent the adhesive from blocking the connection. These procedures are being reviewed to access suitability. The reported event is not occurring more frequently or with greater severity than is usual for the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2090040-2010-00014 |
| MDR Report Key | 1891211 |
| Report Source | 05,06,07 |
| Date Received | 2010-11-04 |
| Date of Report | 2010-11-04 |
| Date of Event | 2010-09-24 |
| Date Mfgr Received | 2010-10-08 |
| Device Manufacturer Date | 2011-08-04 |
| Date Added to Maude | 2012-01-10 |
| 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 | MS. MOIRA BARTON-VARTY |
| Manufacturer Street | 10232 S. 51ST STREET |
| Manufacturer City | PHOENIX AZ 85044 |
| Manufacturer Country | US |
| Manufacturer Postal | 85044 |
| Manufacturer Phone | 4807635300 |
| Manufacturer G1 | ASCENT |
| Manufacturer Street | 10232 SOUTH 51ST STREET |
| Manufacturer City | PHOENIX AZ 85044 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 85044 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | N/A |
| Generic Name | NQG |
| Product Code | NQG |
| Date Received | 2010-11-04 |
| Returned To Mfg | 2010-10-20 |
| Model Number | OM-9000S |
| Catalog Number | OM-9000S |
| Lot Number | 841720SH |
| Device Expiration Date | 2011-08-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENT |
| Manufacturer Address | 10232 SOUTH 51ST STREET PHOENIX AZ 85044 US 85044 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-11-04 |