MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-12-12 for T4 HELMET POWER PACK 0400650000 manufactured by Stryker Instruments-kalamazoo.
[94532443]
It was reported that during testing conducted at the user facility, the device was overheating but did not catch fire. There was no patient involvement, no delay, no medical intervention and no adverse consequences with this event.
Patient Sequence No: 1, Text Type: D, B5
[115214071]
We have evaluated the device.
Patient Sequence No: 1, Text Type: N, H10
[115214072]
It was reported that during testing conducted at the user facility, the device was overheating but did not catch fire. There was no patient involvement, no delay, no medical intervention and no adverse consequences with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2017-02425 |
| MDR Report Key | 7108648 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-12-12 |
| Date of Report | 2018-06-01 |
| Date of Event | 2017-11-13 |
| Date Mfgr Received | 2018-05-22 |
| Device Manufacturer Date | 2017-01-17 |
| Date Added to Maude | 2017-12-12 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ZACHARY 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 | T4 HELMET POWER PACK |
| Generic Name | HELMET, SURGICAL |
| Product Code | FXZ |
| Date Received | 2017-12-12 |
| Returned To Mfg | 2017-11-27 |
| Catalog Number | 0400650000 |
| Lot Number | 17017 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-12-12 |