MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-12-12 for WORKMATE? CLARIS? SYSTEM COMPUTER Z620 H700977 manufactured by St. Jude Medical, Inc..
[170452916]
The results/method and conclusion codes along with investigation results will be provided in the final report further information regarding the event were requested but not received.
Patient Sequence No: 1, Text Type: N, H10
[170452917]
Related manufacturer reference: 2184149-2019-00249. During a procedure, the amplifier and dws were booted and an error message? Amplifier disconnected? Was displayed and an audible alarm was noted from the dws. The devices were power cycled with no resolution and each time they were power cycled,? Database read/write/access error? Would display. A part of the procedure which was atrial fibrillation and supraventricular tachycardia with the use of the ensite system could not be performed and was postponed as the replacement workmate claris devices were unable to be prepared. Therefore, the use of a non-abbott device was required to completed only the atrial fibrillation part of the procedure.
Patient Sequence No: 1, Text Type: D, B5
[188741524]
The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received the cause of the reported error message and subsequent incomplete ablation could not be determined. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184149-2019-00248 |
| MDR Report Key | 9457687 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-12 |
| Date of Report | 2020-03-30 |
| Date of Event | 2019-11-25 |
| Date Mfgr Received | 2020-03-25 |
| Device Manufacturer Date | 2015-11-12 |
| Date Added to Maude | 2019-12-12 |
| 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 | STEPHANIE O' SULLIVAN |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517565400 |
| Manufacturer G1 | ST. JUDE MEDICAL, INC. (AF-ST. PAUL) |
| Manufacturer Street | ONE ST. JUDE MEDICAL DRIVE |
| Manufacturer City | ST. PAUL MN 55117 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55117 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WORKMATE? CLARIS? SYSTEM COMPUTER Z620 |
| Generic Name | COMPUTER, DIAGNOSTIC, PROGRAMMABLE |
| Product Code | DQK |
| Date Received | 2019-12-12 |
| Model Number | H700977 |
| Catalog Number | H700977 |
| Lot Number | 5268159 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, INC. |
| Manufacturer Address | ONE ST. JUDE MEDICAL DRIVE ST. PAUL MN 55117 US 55117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-12-12 |