MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-10 for A&E MEDICAL CORPORATION DISPOSABLE MYO LEAD (DML) 019-540 manufactured by Alto Development Corporation.
[82886224]
Device was discarded at hospital and is not returning to a and e medical for evaluation. A and e medical quality system documentation (complaints, nonconformces, and device history records have been reviewed). These records do not indicate any trends pertaining to this device and the alleged complaint. There are no other complaints within the a and e medical system. This complaint would appear to be an isolated event. The patient was noted as being paced with this device prior to movement of the patient. It is possible the connector could have been damaged while transporting patient from intensive care unit to operating room. A and e medical will continue to monitor its quality system.
Patient Sequence No: 1, Text Type: N, H10
[82886225]
Disposable myo lead cable came unplugged from the pacing box. The patient coded in the cvicu and in the cvor. The connector circumference of the plug was observed having a fracture. The fracture created a "flimsy" interface with the pacing box.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2242056-2017-00003 |
| MDR Report Key | 6784843 |
| Date Received | 2017-08-10 |
| Date of Report | 2017-08-10 |
| Date of Event | 2017-07-12 |
| Date Mfgr Received | 2017-07-12 |
| Date Added to Maude | 2017-08-10 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. BILL KILBY |
| Manufacturer Street | 5206 ASBURY ROAD |
| Manufacturer City | FARMINGDALE NJ 07727 |
| Manufacturer Country | US |
| Manufacturer Postal | 07727 |
| Manufacturer Phone | 7329382266 |
| Manufacturer G1 | ALTO DEVELOPMENT CORPORATION |
| Manufacturer Street | 5206 ASBURY ROAD |
| Manufacturer City | FARMINGDALE NJ 07727 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07727 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | A&E MEDICAL CORPORATION DISPOSABLE MYO LEAD (DML) |
| Generic Name | PATIENT CABLE |
| Product Code | IKD |
| Date Received | 2017-08-10 |
| Model Number | 019-540 |
| Catalog Number | 019-540 |
| Lot Number | UNKNOWN |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALTO DEVELOPMENT CORPORATION |
| Manufacturer Address | 5206 ASBURY ROAD FARMINGDALE NJ 07727 US 07727 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2017-08-10 |