MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2010-06-15 for MICROTEK CPR MICROMASK 73-450 manufactured by Microtek Dominica, S.a..
[1542658]
(b) (6) with (b) (6) ambulance service was dispatched to assist a (b) (6), female, in cardiac arrest. (b) (6) requested assistance from the fire chief, who lived across the street from the location. The fire chief had the micromask in his possession and used the mask along with compression (cpr) to attempt to revive the patient. The fire chief performed cpr for 4 minutes prior to (b) (6) arriving on the scene. The fire chief claimed that air would not flow through the mask. This was confirmed by (b) (6). Compressions continued while the patient was transferred to the hospital. While at the hospital, cardiac rhythm was detected, however, the patient expired. Cause of death was myocardial infarction.
Patient Sequence No: 1, Text Type: D, B5
[8619300]
The device was returned and was visually inspected, photographed, and sent to an independent laboratory for physical evaluation. Results of these tests have not been received. A follow-up report will be submitted upon receipt of the test report from the contracted laboratory.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8043817-2010-00002 |
| MDR Report Key | 1728350 |
| Report Source | 00,05 |
| Date Received | 2010-06-15 |
| Date of Report | 2010-06-15 |
| Date Mfgr Received | 2010-06-08 |
| Date Added to Maude | 2010-06-22 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 602 LEHMBERG ROAD |
| Manufacturer City | COLUMBUS MS 39702 |
| Manufacturer Country | US |
| Manufacturer Postal | 39702 |
| Manufacturer Phone | 8888440988 |
| Manufacturer G1 | MICROTEK DOMINICA, S.A. |
| Manufacturer Street | ZONA FRANCA INDUSTRIAL #2 |
| Manufacturer City | LA ROMANA |
| Manufacturer Country | DR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROTEK CPR MICROMASK |
| Generic Name | CPR MICROMASK (VALVE, NO-REBREATHING) |
| Product Code | CBP |
| Date Received | 2010-06-15 |
| Returned To Mfg | 2010-06-14 |
| Model Number | 73-450 |
| Catalog Number | 73-450 |
| Lot Number | UNK |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROTEK DOMINICA, S.A. |
| Manufacturer Address | LA ROMANA DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2010-06-15 |