MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2020-01-08 for CADD ACCESSORIES BATTERY BATTERY PACK, RECHARGEABLE, LITHIUM ION, 3.7V, 140 21-2160-51 manufactured by Smiths Medical Asd,inc.
[176245701]
Device analysis is done by supplier, which is ultralife corp. Sqe: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[176245702]
Information received a smiths medical cadd assessories battery will only charge and accept 75%. Battery was changed on (b)(6) 2018. No patient adverse events reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-00094 |
| MDR Report Key | 9565742 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2020-01-08 |
| Date of Report | 2020-01-08 |
| Date of Event | 2019-11-23 |
| Date Mfgr Received | 2019-12-10 |
| Date Added to Maude | 2020-01-08 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAVE HALVERSON |
| Manufacturer Street | 6000 LANE N |
| 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 |
| 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 | 3 |
| Brand Name | CADD ACCESSORIES BATTERY |
| Generic Name | ACCESSORIES, PUMP, INFUSION |
| Product Code | MRZ |
| Date Received | 2020-01-08 |
| Returned To Mfg | 2019-12-16 |
| Model Number | BATTERY PACK, RECHARGEABLE, LITHIUM ION, 3.7V, 140 |
| Catalog Number | 21-2160-51 |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD,INC |
| Manufacturer Address | 6000 LANE N MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-08 |