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 2020-02-13 for UNIVERSAL BATTERY CHARGER II 05.001.204 manufactured by Depuy Synthes Products Llc.
[179313102]
Concomitant medical products and therapy dates: power module device (b)(6) 2020). As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Udi? (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[179313103]
It was reported from (b)(6) that prior to a surgical procedure for a lower leg bone shaft fracture, while in the central supply room, it was observed that the battery charger device produced a blue spark when the power module device was plugged into the charger device. It was reported that the charger device then generated white smoke and a burnt smell. It was reported that the staff waited for a while, but the device kept generating the white smoke. This event did not occur during surgery. There was no patient involvement. There were no reports of injuries, medical intervention or prolonged hospitalization. It was reported that the power module had been charged enough and could be used in the surgery without problems. All available information has been disclosed. If additional information should become available, a supplemental medwatch will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2020-00823 |
| MDR Report Key | 9707763 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-13 |
| Date of Report | 2020-01-29 |
| Date of Event | 2020-01-29 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2015-06-18 |
| Date Added to Maude | 2020-02-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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. KARA DITTY-BOVARD |
| Manufacturer Street | EIMATTSTRASSE 3 |
| Manufacturer City | OBERDORF 4436 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 4436 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | WERK OBERD MASCH& KASS (CH) |
| Manufacturer Street | EIMATTSTRASSE 3 |
| Manufacturer City | OBERDORF 4436 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 4436 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNIVERSAL BATTERY CHARGER II |
| Generic Name | BATTERY, REPLACEMENT, RECHARGEABLE |
| Product Code | MOQ |
| Date Received | 2020-02-13 |
| Returned To Mfg | 2020-02-18 |
| Catalog Number | 05.001.204 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES PRODUCTS LLC |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-13 |