MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-06-16 for ATAR D-IS1 2PACE DISPOSABLE EXTENSION CABLE ATAR D-IS1-2PACE manufactured by Oscor Inc.
[77842720]
The conclusion is not yet available, the evaluation is in process. This initial mdr is being submitted to meet our requirements of reporting. A follow-up will be submitted as soon as the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[77842721]
The set screw on the is-1 receptacle portion of the extension did not engage as intended. On 5/8/2017 the following additional information was received from the customer: what is the outcome of the patient? Had to open a permanent generator to pace the patient. No impact to the patient/ patient stable? Yes, delay in care. Was there any adverse effect to the patient? No. Was there any extended hospitalization? No. What procedure the product was used for? Temporary pacer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1035166-2017-00049 |
| MDR Report Key | 6649052 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-06-16 |
| Date of Report | 2018-06-12 |
| Date of Event | 2017-04-20 |
| Date Mfgr Received | 2017-06-26 |
| Device Manufacturer Date | 2017-03-23 |
| Date Added to Maude | 2017-06-16 |
| 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 | MS DORIT SEGAL |
| Manufacturer Street | 3816 DESOTO BLVD |
| Manufacturer City | PALM HARBOR FL 346831816 |
| Manufacturer Country | US |
| Manufacturer Postal | 346831816 |
| Manufacturer Phone | 7279372511 |
| Manufacturer G1 | OSCOR INC |
| Manufacturer Street | 3816 DESOTO BLVD |
| Manufacturer City | PALM HARBOR FL 346831816 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 346831816 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 1035166-06/01/2017-01-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ATAR D-IS1 2PACE DISPOSABLE EXTENSION CABLE |
| Generic Name | CABLE, ELECTRODE |
| Product Code | IKD |
| Date Received | 2017-06-16 |
| Returned To Mfg | 2017-04-20 |
| Model Number | ATAR D-IS1-2PACE |
| Catalog Number | ATAR D-IS1-2PACE |
| Lot Number | C3-17388 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSCOR INC |
| Manufacturer Address | 3816 DESOTO BLVD PALM HARBOR FL 346831816 US 346831816 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-16 |