MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2009-09-01 for LIFELINE EMERGENCY CART LEC 53 manufactured by Intermetro Industries Corporation.
[1177496]
A report was received from (b) (6) hospital, (b) (6), on (b) (6) 2009, with additional information provided on 8/10/09, that an lec cart had malfunctioned during a routine inspection, and that the top compartment could not be readily accessed. No adverse outcome was reported as a result of this issue.
Patient Sequence No: 1, Text Type: D, B5
[8419772]
Intermetro has asked that the unit be returned. We are awaiting a response if this will be possible. A maintenance guideline, including the procedure for lubricating this mechanism, had previously been created. It had been distributed to user facilities as well as distributors and sales force for review and implementation. This maintenance guideline, along with an explantation letter, was sent in august 2008 to all known facilities which had lec carts. Information was provided for users to obtain additional copies for all of their lec carts. The maintenance guideline was also attached to all new lec carts at the manufacturing facility.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1530344-2009-00003 |
| MDR Report Key | 1497351 |
| Report Source | 05,07 |
| Date Received | 2009-09-01 |
| Date of Report | 2009-08-06 |
| Date of Event | 2009-08-06 |
| Date Mfgr Received | 2009-08-10 |
| Device Manufacturer Date | 2005-05-01 |
| Date Added to Maude | 2010-05-28 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 651 N. WASHINGTON STREET |
| Manufacturer City | WILKES-BARRE PA 18705 |
| Manufacturer Country | US |
| Manufacturer Postal | 18705 |
| Manufacturer Phone | 5708252741 |
| Manufacturer Street | 1150 STATE STREET |
| Manufacturer City | FOSTORIA OH 44830 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44830 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFELINE EMERGENCY CART |
| Product Code | BZN |
| Date Received | 2009-09-01 |
| Model Number | LEC 53 |
| Catalog Number | LEC 53 |
| 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 CORPORATION |
| Manufacturer Address | WILKES-BARRE PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-09-01 |