MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2018-09-04 for ELECTRODE ADULT 4.5X6.25 DEFIBRILATION 22550A manufactured by Covidien.
[119108122]
Submit date: 9/4/2018. The incident sample has been requested but to date has not been received for evaluation. If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Patient Sequence No: 1, Text Type: N, H10
[119108123]
The customer reports the defibrillator electrode was not providing any trace from the patient. They attempted to use two electrodes from the same lot on the same patient and received the same result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219103-2018-00201 |
| MDR Report Key | 7843118 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2018-09-04 |
| Date of Report | 2018-12-04 |
| Date of Event | 2018-08-17 |
| Date Mfgr Received | 2018-08-20 |
| Date Added to Maude | 2018-09-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 2 LUDLOW PARKWAY |
| Manufacturer City | CHICOPEE MA 01022 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01022 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELECTRODE ADULT 4.5X6.25 DEFIBRILATION |
| Generic Name | PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE) |
| Product Code | MLN |
| Date Received | 2018-09-04 |
| Model Number | 22550A |
| Catalog Number | 22550A |
| Lot Number | 807479X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 2 LUDLOW PARKWAY CHICOPEE MA 01022 US 01022 |
| Brand Name | ELECTRODE ADULT 4.5X6.25 DEFIBRILATION |
| Generic Name | PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE) |
| Product Code | DRO |
| Date Received | 2018-09-04 |
| Model Number | 22550A |
| Catalog Number | 22550A |
| Lot Number | 807479X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 2 LUDLOW PARKWAY CHICOPEE MA 01022 US 01022 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-04 |