MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-11 for KENDALL 33103 manufactured by Cardinal Health.
[182991885]
Electrocardiogram wires are intermittently cutting off displaying asystole and no respiratory rate. Then will return to normal display. Manufacturer response for disposable cable and lead wire system, kandall (per site reporter). Device sent for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9817869 |
| MDR Report Key | 9817869 |
| Date Received | 2020-03-11 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-02-22 |
| Report Date | 2020-02-27 |
| Date Reported to FDA | 2020-02-27 |
| Date Reported to Mfgr | 2020-03-11 |
| Date Added to Maude | 2020-03-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KENDALL |
| Generic Name | CABLE, ELECTRODE |
| Product Code | IKD |
| Date Received | 2020-03-11 |
| Returned To Mfg | 2020-02-26 |
| Model Number | 33103 |
| Catalog Number | 33103 |
| Lot Number | 038480 |
| Device Availability | R |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | 15 HAMPSHIRE STREET BUILDING 5 MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-11 |