MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2009-10-16 for CAMERA CONTROL UNIT HD 560P 72200559 manufactured by Oklahoma City Manufacturing Site.
[1309322]
Just shipped. Out of box failure. Went to turn unit on. Pt was asleep and there was not a picture at all. Had to cancel the case and the one after.
Patient Sequence No: 1, Text Type: D, B5
[8406092]
All outputs perform as expected during 6 hour burn-in. No problem found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1643264-2009-00110 |
| MDR Report Key | 1511262 |
| Report Source | 06,07 |
| Date Received | 2009-10-16 |
| Date of Report | 2009-09-16 |
| Date of Event | 2009-09-16 |
| Date Facility Aware | 2009-09-16 |
| Report Date | 2009-10-16 |
| Date Mfgr Received | 2009-09-16 |
| Device Manufacturer Date | 2008-11-18 |
| Date Added to Maude | 2009-10-22 |
| 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 | JASON BILOBRAM |
| Manufacturer Street | 150 MINUTEMAN RD. |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9787491630 |
| Manufacturer G1 | OKLAHOMA CITY MANUFACTURING SITE |
| Manufacturer Street | 76 S. MERIDIAN AVE. |
| Manufacturer City | OKLAHOMA CITY OK 73107651 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 73107 6512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAMERA CONTROL UNIT HD 560P |
| Generic Name | CAMERA CONTROL UNIT HD 560P/GCJ |
| Product Code | ODA |
| Date Received | 2009-10-16 |
| Returned To Mfg | 2009-10-09 |
| Model Number | 72200559 |
| Catalog Number | 72200559 |
| Lot Number | AAW1739 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 11 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OKLAHOMA CITY MANUFACTURING SITE |
| Manufacturer Address | OKLAHOMA CITY OK US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-10-16 |