MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-29 for SEDASYS PRU CONTROL UNIT SEDPRU01 manufactured by Ethicon Endo Surgery, Inc (cincinnati).
[61296895]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
[61296896]
It was reported that there is an issue with the door latch on the device. The pump door will not stay closed. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[64745687]
(b)(4) date sent: 1/3/2017. Per service manual operational and diagnostic analysis does confirm the pump door does not stay latched due to cracked latch.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1527736-2016-00048 |
| MDR Report Key | 6131721 |
| Date Received | 2016-11-29 |
| Date of Report | 2016-11-09 |
| Date of Event | 2016-11-09 |
| Date Mfgr Received | 2016-12-12 |
| Date Added to Maude | 2016-11-29 |
| 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 | MILTON GARRETT |
| Manufacturer Street | 4545 CREEK ROAD ML 120A |
| Manufacturer City | CINCINNATI OH 45242 |
| Manufacturer Country | US |
| Manufacturer Postal | 45242 |
| Manufacturer Phone | 5133378865 |
| 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 PRU CONTROL UNIT |
| Generic Name | COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM |
| Product Code | PDR |
| Date Received | 2016-11-29 |
| Returned To Mfg | 2016-11-21 |
| Model Number | NA |
| Catalog Number | SEDPRU01 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON ENDO SURGERY, INC (CINCINNATI) |
| Manufacturer Address | 4545 CREEK RD CINCINNATI OH 452422803 US 452422803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-29 |