MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07,08 report with the FDA on 2009-06-08 for LIFELINE EMERGENCY CART LEC 51 manufactured by Intermetro Industries Corp..
[1265155]
A report was rec'd from (b) (6), (b) (6) on 5/7/09 that an lec cart had malfunctioned during a code, inhibiting access to medications stored in the top compartment of the cart. No adverse outcome was reported as a result of this issue.
Patient Sequence No: 1, Text Type: D, B5
[8311000]
A guideline for product maintenance, including the procedure for lubricating this mechanism, had previously been created. It has been distributed to user facilities as well as distributors and salesforce for review and implementation. The mechanism was evaluated upon return and was operating normally; no lubrication was noted on the moving components of the mechanism as prescribed in the maintenance procedure. It was also noted that one small plastic bushing, used to reduce sliding friction, was missing; it is unclear if this occurred before of after replacement. No excessive wear was noted at this interface.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1530344-2009-00001 |
| MDR Report Key | 1461766 |
| Report Source | 01,05,06,07,08 |
| 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 | 2005-02-01 |
| Date Added to Maude | 2010-03-31 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| 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 |
| Returned To Mfg | 2009-06-03 |
| Model Number | LEC 51 |
| Catalog Number | LEC 51 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 |