MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-15 for MYOENERGY INTEGRAL 757B35=0 manufactured by Otto Bock Healthcare Products Gmbh.
[43625260]
The cause of the malfunction is a defective electronic component of the battery charger.
Patient Sequence No: 1, Text Type: N, H10
[43625261]
The myo energy integral battery was connected to the charger by the cpo prior to the fitting of an external upper limb prosthesis. After about two (2) hours of charging the battery inflamed. The fire was discovered immediately by an employee around and could be extinguished. No consequences or impact to patient or other persons.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615892-2016-00006 |
| MDR Report Key | 5580346 |
| Date Received | 2016-04-15 |
| Date of Report | 2016-04-15 |
| Date of Event | 2016-03-21 |
| Date Mfgr Received | 2016-03-22 |
| Device Manufacturer Date | 2016-01-14 |
| Date Added to Maude | 2016-04-15 |
| 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 | MR REINHARD WOLKERSTORFER |
| Manufacturer Street | BREHMSTRASSE 16 |
| Manufacturer City | VIENNA, VIENNA 1110 |
| Manufacturer Country | AU |
| Manufacturer Postal | 1110 |
| Manufacturer G1 | OTTO BOCK HEALTHCARE PRODUCTS GMBH |
| Manufacturer Street | BREHMSTRASSE 16 |
| Manufacturer City | VIENNA, VIENNA 1110 |
| Manufacturer Country | AU |
| Manufacturer Postal Code | 1110 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MYOENERGY INTEGRAL |
| Generic Name | BATTERY PACK |
| Product Code | IQZ |
| Date Received | 2016-04-15 |
| Returned To Mfg | 2016-03-24 |
| Model Number | 757B35=0 |
| Lot Number | 0012 2016 02 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OTTO BOCK HEALTHCARE PRODUCTS GMBH |
| Manufacturer Address | BREHMSTRASSE 16 VIENNA, VIENNA 1110 AU 1110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-15 |