MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-13 for CADD ACCESSORIES 21-2160-12 manufactured by Smiths Medical, Asd, Inc..
[120396443]
(b)(6). Unable to provide expiration date and device manufacturer date of the device.
Patient Sequence No: 1, Text Type: N, H10
[120396444]
It was reported that while using a cadd accessory, a battery pack, the pump shuts down as if there is no power. Looking at the event log, it looks like the power cable is taken in and out, but that's not the case. It might be the rechargeable battery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2018-03885 |
| MDR Report Key | 7874816 |
| Date Received | 2018-09-13 |
| Date of Report | 2018-12-04 |
| Date of Event | 2018-08-02 |
| Date Mfgr Received | 2018-11-05 |
| Date Added to Maude | 2018-09-13 |
| 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 | DAVE HALVERSON |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833310 |
| Manufacturer G1 | SMITHS MEDICAL, ASD, INC. |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55442 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CADD ACCESSORIES |
| Generic Name | BATTERIES, RECHARGEABLE, FOR CLASS 2 DEVICES |
| Product Code | MOX |
| Date Received | 2018-09-13 |
| Returned To Mfg | 2018-08-24 |
| Catalog Number | 21-2160-12 |
| Lot Number | 0000012 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL, ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-13 |