MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-23 for VENTILATORS PNEUPAC VENTILATORS VR1 AIR MIX VR1AIRNSE manufactured by Smiths Medical Asd,inc..
[184545092]
Investigation results completed on a smiths medical pneupac ventilators vr1 air mix. Reported a video was attached to reveal show what was issue but it was video upside down, so therefore unable to watch. The device was used as a demo and upon visual inspection, this revealed cracked in lower case adn hile in the momentary control rubber. This is believed to be caused by wear and tear of often usage. Device was tested and multiple issues found with fault found do to damage. The engineer conclusion: as this was a demo unit, it is suggested that the number of lever operations must have exceeded the number set out in the requirements specification for this device. Consequently, this led to uncharacteristic wear of the mating components and build-up of debris which ultimately led to the leak and failure mode of constant. Action was taken to replace damage parts.
Patient Sequence No: 1, Text Type: N, H10
[184545093]
?information received a smiths medical pneupac ventilators vr1 air mix testing was being done and the vr 1 did not break the breath and kept blowing . this occurred three times . event was during testing and no patient involvement .
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02194 |
| MDR Report Key | 9868183 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2020-03-23 |
| 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 | DAVE HALVERSON |
| Manufacturer Street | 6000 LANE N |
| Manufacturer City | MINNEAPOLIS, MN |
| Manufacturer Country | US |
| Manufacturer Phone | 3833310 |
| Manufacturer G1 | SMITHS MEDICAL INTERNATIONAL LTD., |
| Manufacturer Street | ENTERPRISE WAY, |
| Manufacturer City | LUTON, LONDON |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VENTILATORS PNEUPAC VENTILATORS VR1 AIR MIX |
| Generic Name | VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) |
| Product Code | BTL |
| Date Received | 2020-03-23 |
| Returned To Mfg | 2020-03-04 |
| Catalog Number | VR1AIRNSE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD,INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-23 |