MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-05-27 for SEDASYS CONTROL UNIT SEDPRU01 manufactured by Ethicon Endo Surgery, Inc (cincinnati).
[18657173]
It was reported that the cassette door was popping open independently during the procedure. The nurse shut the door and sometimes it stayed closed, and sometimes it popped open again. There was no patient consequence.
Patient Sequence No: 1, Text Type: D, B5
[19139427]
(b)(4). The unit was received with cosmetic issues to the front and upper bezel. During the analysis, the pump door issue was confirmed resulting in the replacement of the infusion pump. To address the cosmetic issues, the front and upper bezel were replaced. As part of replacing the bezels, the power switch and foam gasket were also replaced. The repair and testing of the unit was completed and the unit passed all functional tests.
Patient Sequence No: 1, Text Type: N, H10
[30337978]
(b)(4). Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event and has been revised to not reportable.
Patient Sequence No: 1, Text Type: N, H10
[30337995]
(b)(4). Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event and has been revised to not reportable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1527736-2015-00012 |
| MDR Report Key | 4799416 |
| Report Source | 05,06 |
| Date Received | 2015-05-27 |
| Date of Report | 2015-02-27 |
| Date of Event | 2015-02-26 |
| Date Mfgr Received | 2015-07-22 |
| Date Added to Maude | 2015-06-24 |
| 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 | 0 |
| Manufacturer Contact | GUILLERMO VILLA |
| Manufacturer Street | ROUTE 22 WEST PO BOX 151 |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082180707 |
| Manufacturer G1 | MACK MOLDING COMPANY |
| Manufacturer Street | 608 WARM BROOK RD |
| Manufacturer City | ARLINGTON VT 05250 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 05250 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SEDASYS CONTROL UNIT |
| Generic Name | SEDASYS CONTROL UNIT |
| Product Code | PDR |
| Date Received | 2015-05-27 |
| Returned To Mfg | 2015-03-10 |
| Model Number | NA |
| Catalog Number | SEDPRU01 |
| Lot Number | NA |
| ID Number | 10705036010203 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON ENDO SURGERY, INC (CINCINNATI) |
| Manufacturer Address | 4545 CREEK RD CINCINNATI OH 45242280 US 45242 2803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-27 |