MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-02-07 for MRI TRANSPORT CIRCUIT 9317 manufactured by Westmed.
[3990409]
The design of the transport breathing vent circuit allows the connector to be hooked up incorrectly. Pt was placed at portable ventilator; pt's sats were noted to desat to 50s briefly pt went into rapid afib when sats dropped, but returned to baseline with improved sats after being placed on standard ventilator.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5034428 |
| MDR Report Key | 3628149 |
| Date Received | 2014-02-07 |
| Date of Report | 2014-02-07 |
| Date of Event | 2014-01-23 |
| Date Added to Maude | 2014-02-18 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MRI TRANSPORT CIRCUIT |
| Generic Name | PEEP VALVE, VENT CIRCUIT + PATIENT VALVE |
| Product Code | BYE |
| Date Received | 2014-02-07 |
| Returned To Mfg | 2014-02-10 |
| Model Number | 9317 |
| Lot Number | 08272013401 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WESTMED |
| Manufacturer Address | 5580 S. NOGALES HIGHWAY TUCSON AZ 85706 US 85706 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-02-07 |