MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07,08 report with the FDA on 2009-06-08 for LIFELINE EMERGENCY CART LEC 51 manufactured by Intermetro Industries Corp..
[20162902]
The backboard for the cart was reported to have cracked while being used as part of a cardiac code. While the pt subsequently died, it was reported by the hosp that there was no causal relationship. It was reported that the backboard was original to the cart which was sold in 2001, and that a crack was noted on the board prior to use. The backboard was disposed of by the facility, so no analysis or inspection was possible.
Patient Sequence No: 1, Text Type: D, B5
[20398705]
A change was made to the backboard material in 2003 and in 2005. A warning label as added to the backboard advising to periodically inspect the board and to replace if worn or damaged. In 2008, a letter was distributed to all known user facilities to replace backboards at least once every five years and to inspect/replace boards that are worn or damaged. It was advised that our norway distributor had received this notification and forwarded it to end user facilities including this hosp. It was reported that this board was original to the cart and that damaged had been noted prior to this usage. The backboard was disposed of by the facility, so no further review or inspection could be conducted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1530344-2009-00002 |
| MDR Report Key | 1461765 |
| Report Source | 01,06,07,08 |
| Date Received | 2009-06-08 |
| Date of Report | 2009-05-27 |
| Date of Event | 2009-05-07 |
| Date Mfgr Received | 2009-05-08 |
| Device Manufacturer Date | 2001-07-01 |
| Date Added to Maude | 2010-03-30 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 651 N WASHINGTON ST |
| Manufacturer City | WILKES-BARRE PA 18705 |
| Manufacturer Country | US |
| Manufacturer Postal | 18705 |
| Manufacturer Phone | 5708252741 |
| Manufacturer Street | 1150 STATE ST. |
| Manufacturer City | FOSTORIA OH 44830 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44830 |
| Single Use | 3 |
| Remedial Action | RB |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFELINE EMERGENCY CART |
| Product Code | BZN |
| Date Received | 2009-06-08 |
| Model Number | LEC 51 |
| Catalog Number | LEC 51 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERMETRO INDUSTRIES CORP. |
| Manufacturer Address | WILKES-BARRE PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-06-08 |