MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2014-03-18 for 9317 manufactured by Na.
[4303359]
Mri circuit was incorrectly connected to pt resulting in arrythmia and desaturation of pt. Pt was then bagged with resuscitation and o2 level rose to normal. This is how the original complaint was reported by (b)(6) to westmed. This medwatch is a response of a maude event report no. (b)(4) submitted (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[11594057]
Per attached operating instructions label pn 75282 explained how to attach the circuit pursuant to standard operating protocol under "suggested use, step 1". There is a section specifically for the peep valve operating instructions and cautions and warning such as "all users of this device should read instructions for use of the circuit and associated transport equipment... " as a result of this complaint and is order to make the instruction and the device more clear to operate, it was added a label to the peep valve with big arrows defining well the tubing connection and pt connection are, this way, even though the user doesn't read the instruction for use, it will be visible and evident how to attach the circuit and the proper way to hook up the connectors correctly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028807-2014-00001 |
| MDR Report Key | 3690750 |
| Report Source | 00 |
| Date Received | 2014-03-18 |
| Date of Report | 2014-03-18 |
| Date of Event | 2014-01-23 |
| Date Mfgr Received | 2014-03-17 |
| Device Manufacturer Date | 2013-08-01 |
| Date Added to Maude | 2014-04-18 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LUIS BURGOS |
| Manufacturer Street | 5580 S. NOGALES HIGHWAY |
| Manufacturer City | TUCSON AZ 85706 |
| Manufacturer Country | US |
| Manufacturer Postal | 85706 |
| Manufacturer Phone | 5202947987 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NA |
| Generic Name | MRI TRANSPORT CIRCUIT |
| Product Code | BYE |
| Date Received | 2014-03-18 |
| Model Number | 9317 |
| Catalog Number | NA |
| Lot Number | 08272013401 |
| ID Number | NA |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NA |
| Manufacturer Address | NA NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2014-03-18 |