MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-05 for ATAR D-A, DARK BLUE DISPOSABLE manufactured by Oscor Inc..
[123810444]
The device was in use for treatment. The user noted that the patient death is related to a patient condition. The pacer had nothing to do with it. The device was not returned and there was no specific performance related failure reported by the user. The lot number of this device was not provided, therefore a review of the device history record or complaint history could not be performed. Inspection procedures require any oscor product to pass all in-process and qa final inspections before shipping to the customer. Per quality assurance atar cable in process and final inspection procedure: in process inspection, inspect 100% for continuity. A) connect black shrouded pin and black pin receptacle to the multimeter and verify continuity is present. The reading shall be less than 2. 0 ohms. The multimeter display should be steady, not erratic. B) repeat the same for the red shrouded pin and red pin receptacle. In final inspection, inspect 100% for continuity. A) connect black shrouded pin and black pin receptacle to the multimeter and verify continuity is present. The reading shall be less than 2. 0 ohms. The multimeter display should be steady, not erratic. B) repeat the same for the red shrouded pin and red pin receptacle. Per instructions for use (ifu) it cautions the user: prior to use, read all package inserts, warnings, precautions, and instructions. Failure to do so may result in severe patient injury or death. Do not connect any cable model to a/c power source; connection of exposed pins to a/c power source may pose a risk of serious injury or death. Extension cables are not intended for use with apnea monitors. The directions for use state: first attach the proximal connector(s) to a pacemaker/analyzer or another extension cable while observing polarity indicated by the color. Then attach the distal connector(s) to the temporary lead connector or to another extension cable, again observing polarity by the color. The detachment of the connection should be done in the reverse order.
Patient Sequence No: 1, Text Type: N, H10
[123810445]
It was reported the hospital was having issues with our atar cables not staying connected to their transvenous pacing leads and myocardial pacing wires. They are having trouble with leads pulling out from the distal end of the atar cables after the receptacle connector is tightened down. They stated that it has happened several times and sometimes in emergency situations where the nursing staff have gloves on and possibly blood which may affect their ability to tighten down the connector. They said they have had multiple issues where they lost capture/pacing several times in critical patients due to connection issues. The reporter was not able to get the brand/models of the temporary transvenous pacing leads (cath lab) or the temporary pacing wires (cvor) currently used by the hospital. Per the hospital, the device model number is atar d-a. On 13-sep-2018 additional information was received the patient had expired on (b)(6) 2018. During cath procedure patient coded. It was related to patient condition; the pacer had nothing to do with it. The hospital does not have the lot number, and the device is not available for evaluation. They reported this is not a one-time incident. It's not the wire pulling out. The nursing staff have gloves on and possibly blood which may affect their ability to tighten down the connector.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1035166-2018-00090 |
| MDR Report Key | 7938460 |
| Date Received | 2018-10-05 |
| Date of Report | 2018-10-19 |
| Date of Event | 2018-08-13 |
| Date Mfgr Received | 2018-10-15 |
| Date Added to Maude | 2018-10-05 |
| 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 | MR. DOUG MYERS |
| Manufacturer Street | 3816 DE SOTO BLVD. |
| Manufacturer City | PALM HARBOR FL 34683 |
| Manufacturer Country | US |
| Manufacturer Postal | 34683 |
| Manufacturer Phone | 7279372511 |
| Manufacturer G1 | OSCOR INC. |
| Manufacturer Street | 3816 DE SOTO BLVD. |
| Manufacturer City | PALM HARBOR FL 34683 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 34683 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ATAR D-A, DARK BLUE DISPOSABLE |
| Generic Name | CABLE, ELECTRODE |
| Product Code | IKD |
| Date Received | 2018-10-05 |
| Model Number | ATAR D-A |
| Catalog Number | ATAR D-A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSCOR INC. |
| Manufacturer Address | 3816 DE SOTO BLVD. PALM HARBOR FL 34683 US 34683 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-05 |