MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2011-04-13 for 3M RED DOT NEONATAL MONITORING ELECTRODES 2269T manufactured by 3m Health Care.
[1983579]
A 3m (b)(4) stated the customer reported that when the (b)(4) 3m red dot neonatal monitoring electrodes are plugged into the lead, the machine states "left leg off". Replacement product was sent to the sales representative. The affected sample was sent to 3m and analyzed. Testing found that the defect was isolated to the red wires from mn wire lot 100827. Mn wire has been contacted and will investigate internally to determine a root cause and how much of the lead wire inventory is affected. 3m will continue to monitor for this defect. Corrective action has been recommended.
Patient Sequence No: 1, Text Type: D, B5
[9122911]
Patient information was not available/no patient(s) involved in the complaint. No adverse patient effects were reported. If additional information is received, a follow-up report will be submitted. Electrical wire.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2110898-2011-00039 |
| MDR Report Key | 2083181 |
| Report Source | 04,07 |
| Date Received | 2011-04-13 |
| Date of Report | 2011-03-15 |
| Date of Event | 2011-02-02 |
| Date Mfgr Received | 2011-03-15 |
| Device Manufacturer Date | 2010-08-01 |
| Date Added to Maude | 2011-05-31 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ANDREA GRABANSKI |
| Manufacturer Street | 3M CENTER, BLDG. 275-5W-06 |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517331047 |
| Manufacturer G1 | 3M CANADA |
| Manufacturer Street | 400 RT 100 |
| Manufacturer City | MORDEN, MANITOBA R6M1Z9 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | R6M 1Z9 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M RED DOT NEONATAL MONITORING ELECTRODES |
| Generic Name | 870.2360 ELECTROCARDIOGRAPH ELECTRODE |
| Product Code | FPX |
| Date Received | 2011-04-13 |
| Model Number | NA |
| Catalog Number | 2269T |
| Lot Number | 2012-08 PJ |
| ID Number | NA |
| Device Expiration Date | 2012-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | ST. PAUL MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-13 |