MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-09-29 for METRO LIFELINE LEC 9150 * manufactured by *.
[18445533]
In 2003, representative to clinic called co to order a replacement backboard. Questioning by co's customer service representative revealed that the board reportedly cracked during reanimation of the patient with heart pressure massage. The board was replaced and patient was successfully resuscitated. There are no known adverse results for the reported event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530344-2003-00001 |
| MDR Report Key | 487178 |
| Date Received | 2003-09-29 |
| Date of Report | 2003-09-17 |
| Date of Event | 2003-08-25 |
| Date Mfgr Received | 2003-09-08 |
| Date Added to Maude | 2003-10-07 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | DAVID REPPERT |
| Manufacturer Street | 651 N. WASHINGTON ST. |
| Manufacturer City | WILKES-BARRE PA 18705 |
| Manufacturer Country | US |
| Manufacturer Postal | 18705 |
| Manufacturer Phone | 5707063114 |
| Manufacturer G1 | INTERMETRO INDUSTRIES CORP |
| Manufacturer Street | 1150 STATE STREET |
| Manufacturer City | FOSTORIA OH 44830 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44830 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | METRO LIFELINE |
| Generic Name | BOARD, CARDIOPULMONARY |
| Product Code | FOA |
| Date Received | 2003-09-29 |
| Returned To Mfg | 2003-09-08 |
| Model Number | LEC 9150 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 476067 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Baseline Brand Name | METRO LIFELINE |
| Baseline Generic Name | BOARD, CARDIOPULMONARY |
| Baseline Model No | LEC 9150 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-09-29 |