MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-11-28 for POWER PACK, EXTENDED LIFE 0408660000 manufactured by Stryker Instruments-kalamazoo.
[128744230]
The user facility reported that when a flyte battery was connected to the flyte helmet prior to an operation, the battery began to smoke and later began to burn with a small flame. The battery was removed from the flyte helmet and put into water in a sink. The user facility also reported that the battery was dropped on the floor prior to connecting the battery with the helmet. No patient involvement with this event.
Patient Sequence No: 1, Text Type: D, B5
[132246266]
Device not available for evaluation; however, images were provided for examination. Lot number and manufacture date updated. Correction: device code changed to reflect updated information provided. Device not returned; however, images were provided for examination.
Patient Sequence No: 1, Text Type: N, H10
[132246267]
The user facility reported that when a flyte battery was connected to the flyte helmet prior to an operation, the battery began to smoke and later began to burn with a small flame. The battery was removed from the flyte helmet and put into water in a sink. The user facility also reported that the battery was dropped on the floor prior to connecting the battery with the helmet. No patient involvement with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2018-02570 |
| MDR Report Key | 8112138 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-11-28 |
| Date of Report | 2019-01-07 |
| Date of Event | 2018-11-06 |
| Date Mfgr Received | 2018-11-06 |
| Device Manufacturer Date | 2017-07-20 |
| Date Added to Maude | 2018-11-28 |
| 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. ZACH BAKER |
| 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 | POWER PACK, EXTENDED LIFE |
| Generic Name | HELMET, SURGICAL |
| Product Code | FXZ |
| Date Received | 2018-11-28 |
| Catalog Number | 0408660000 |
| Lot Number | 2017-07-20 |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-11-28 |