MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-01-29 for BATTERY 4115000000 manufactured by Stryker Instruments-kalamazoo.
[37065416]
This report was reported in error under the alternative report number (b)(4) on (b)(6)2014. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[37065417]
It was reported that the system 4/5 large battery was allegedly smoking while on the battery charger. There was no patient involvement and no adverse consequences associated with the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2016-00107 |
| MDR Report Key | 5398062 |
| Report Source | USER FACILITY |
| Date Received | 2016-01-29 |
| Date of Report | 2013-06-19 |
| Date of Event | 2013-06-18 |
| Date Mfgr Received | 2013-06-19 |
| Device Manufacturer Date | 2012-06-13 |
| Date Added to Maude | 2016-01-29 |
| 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 | MR. CASEY METZGER |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal | 49001 |
| Manufacturer Phone | 2693237700 |
| Manufacturer G1 | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BATTERY |
| Generic Name | INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT |
| Product Code | KIJ |
| Date Received | 2016-01-29 |
| Catalog Number | 4115000000 |
| Lot Number | 12165 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Address | 4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-29 |