MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-10-12 for LIFELINE CODE RESPONSE CART LEC323 manufactured by Intermetro Industries.
[21669163]
The initial reporter stated the hosp had a code and "the pt required cpr and the board broke under the pt during cpr. " the device is being shipped back for eval. The local sales office has received the device and stated "it looks in pretty rough shape - scratched and cracked. " the device has a label which reads: warning backboard must be inspected after each use. Do not use if chipped, cracked or badly scratched. Damaged board could result in failure during cpr. Damaged board could result in inadequate support. Our initial belief based on the sales office's description of the board is that this is a safety concern caused by a lack of inspection at the user facility.
Patient Sequence No: 1, Text Type: D, B5
[21887336]
Intermetro has requested the backboard be returned for eval. Replacement board has been sent to hosp. Intermetro contacted the initial reporter, kyle leslie, senior buyer, at the user facility, for more info. Mr (b)(6) said he would determine who was the health professional that was familiar with the event and have them contact intermetro. Mr (b)(6) was contacted by phone on (b)(6) 2012 and again on (b)(6) 2012. Mr (b)(6) was sent an e-mail on (b)(6) 2012 and again on (b)(6) 2012. No additional info has been received from mr (b)(6) or a health professional. The device has been shipped to intermetro. After the device is received and evaluated, another call will be made to the user facility with our findings.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1530344-2012-00001 |
| MDR Report Key | 2835532 |
| Report Source | 07 |
| Date Received | 2012-10-12 |
| Date of Report | 2012-10-12 |
| Date of Event | 2012-09-01 |
| Date Mfgr Received | 2012-09-20 |
| Date Added to Maude | 2013-01-29 |
| 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 Contact | WILLARD SICKLES |
| Manufacturer Street | 651 N WASHINGTON ST |
| Manufacturer City | WILKES-BARRE PA 18705 |
| Manufacturer Country | US |
| Manufacturer Postal | 18705 |
| Manufacturer Phone | 5707063121 |
| Manufacturer G1 | INTERMETRO INDUSTRIES |
| Manufacturer Street | 1150 STATE ST. |
| Manufacturer City | FOSTORIA OH 44830 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44830 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFELINE CODE RESPONSE CART |
| Product Code | BZN |
| Date Received | 2012-10-12 |
| Model Number | LEC323 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERMETRO INDUSTRIES |
| Manufacturer Address | FOSTORIA OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-12 |