MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-09-26 for 3M DEFIB PADS N/A 2345N manufactured by 3m Infection Prevention.
[87439105]
No title of the initial reporter was provided. This complaint is linked to 2110898-2017-00131. Since a different product was used and replaced the product used under this complaint. Product has been shipped to 3m for evaluation but not received yet for evaluation. It was noted the pads looked normal and were wet. End of report
Patient Sequence No: 1, Text Type: N, H10
[87439106]
A male patient in cardiac arrest underwent defibrillated using 3m defib pads (consisting of electro conductive gel). There was no sign of electric conductivity during initial defibrillation nor a response from the patient. The 3m defib pads were removed and replaced with new set and different catalog number. Patient subsequently died. It was confirmed the defibrillator used with these specific defibs pads worked according to the manufacturer's specifications.
Patient Sequence No: 1, Text Type: D, B5
[96238671]
The following information was not included in the initial report. A statement from the biomedical engineer of the hospital indicates testing was conducted on all items and worked in the correct way. The method biomedical engineer used to evaluate the defib pads was not specifically stated. The assumption is the testing was a visual for wetness. However, all production data from lot 2018-11au applies to model 2345n was reviewed. All production data was normal and there were no ncns for issues recorded during the run of this lot. All release testing of this lot passed all specifications. Data from the coating step of this lot was reviewed as well, and all data was within specification with no recorded nonconformances. A total of six retains samples were examined from lot 2018-11au. All 6 retains were tested for impedance and all 6 samples were within specification. End of report.
Patient Sequence No: 1, Text Type: N, H10
[96238672]
Additional information: application of a first set of patches (2345n) was placed onto the patient and two external shocks using the same defibrillator was give to the patient. No sign of conduction. Another set of pads were applied using a different model number.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2017-00130 |
| MDR Report Key | 6896056 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-09-26 |
| Date of Report | 2017-10-02 |
| Date of Event | 2017-08-24 |
| Date Mfgr Received | 2017-09-27 |
| Device Manufacturer Date | 2015-11-01 |
| Date Added to Maude | 2017-09-26 |
| 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. LINDA JOHNSEN |
| Manufacturer Street | 2510 CONWAY AVE |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517374376 |
| Manufacturer G1 | 3M COMPANY BROOKINGS |
| Manufacturer Street | 601 22ND AVE SOUTH |
| Manufacturer City | BROOKINGS SD 57006 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 57006 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M DEFIB PADS |
| Generic Name | CONDUCTIVE GEL |
| Product Code | GYB |
| Date Received | 2017-09-26 |
| Model Number | N/A |
| Catalog Number | 2345N |
| Lot Number | 2018-11 AU |
| Device Expiration Date | 2018-11-01 |
| 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 INFECTION PREVENTION |
| Manufacturer Address | 2510 CONWAY AVENUE ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2017-09-26 |