MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-31 for MASTERSCREEN IOS 001-176450 manufactured by Carefusion, Inc.
[41780893]
This mdr is being submitted due to a retrospective complaint review performed by carefusion. The carefusion identification file is (b)(4). A carefusion field service engineer evaluated the device at the customer's facility and found the screws had been stripped. The screws were replaced and the arm is now functioning as intended. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[41780894]
It was reported via a carefusion field service engineer that the customer stated the arm holding the impulse oscillometer (ios) head became disconnected from the cart and fell onto the patient's lap during testing. The patient was a large male and he caught the ios/arm assembly. There was no harm done to the patient.
Patient Sequence No: 1, Text Type: D, B5
[44796982]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615102-2016-00001 |
| MDR Report Key | 5540136 |
| Date Received | 2016-03-31 |
| Date of Report | 2014-08-11 |
| Date of Event | 2014-08-11 |
| Date Mfgr Received | 2016-04-21 |
| Date Added to Maude | 2016-03-31 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JILL RITTORNO |
| Manufacturer Street | 22745 SAVI RANCH PARKWAY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer Phone | 7149227830 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | LIEBNIZSTRASSE 7 |
| Manufacturer City | HOECHBERG 97204 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 97204 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MASTERSCREEN IOS |
| Generic Name | SPIROMETER, DIAGNOSTIC |
| Product Code | BZG |
| Date Received | 2016-03-31 |
| Model Number | MASTERSCREEN IOS |
| Catalog Number | 001-176450 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | LIEBNIZSTRASSE 7 HOECHBERG 97204 GM 97204 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-03-31 |