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 2015-10-21 for PLETHYSMOGRAPH, PRESSURE MS-BABY BODY TP 001-175550 manufactured by Carefusion.
[28802394]
Carefusion file identification number (b)(4). Any additional information received from the customer will be included in a follow-up report. (b)(4). The device has not been received by carefusion.
Patient Sequence No: 1, Text Type: N, H10
[28802395]
It was reported by the customer that the shutter balloon test failed and received a "shutter pressure zero fail" message and the data was lost for the patient. After troubleshooting with field service engineer (fse) it is unknown if the reported issue has been corrected. The customer stated due to the equipment being non-operational they had to perform a more invasive diagnostic test (bronchoscopy) and the loss of data from the pulmonary function test contributed to a delay in the patient's diagnosis.
Patient Sequence No: 1, Text Type: D, B5
[32588219]
A functional check was done by a carefusion failure analysis technician. The computer was booted up and the device manager was accessed. The video card was recognizable to the system. There were no problems found on the video card and the video card is functioning properly. In conclusion, the customer? S complaint of? Winnov card not being recognized? And shutter problem could not be confirmed. Failure analysis indicated there was no damage or burnt components on video card and the operational/functional check was normal. There was no problem found. As a result of not being able to duplicate the customer? S experience, a conclusive root cause could not be identified.
Patient Sequence No: 1, Text Type: N, H10
[44187455]
Results of investigation: the carefusion failure analysis lab received the paediatric pneumotach and performed a failure investigation. The device worked as expected to service specifications and the failure could not be duplicated. The carefusion failure analysis lab received a second component to evaluate, the ms paediatric handle, and an investigation was completed. It was determined that this was the wrong component for the primary device. The wrong part number was ordered for the product so the component was incompatible for proper usage and could not be installed properly.
Patient Sequence No: 1, Text Type: N, H10
[45444813]
Results of investigation: the carefusion failure analysis lab received the board ssb and performed a failure investigation. The device was received in a damaged condition and when tested, the component was hot and non-functioning. No further investigation was possible.
Patient Sequence No: 1, Text Type: N, H10
[50372142]
Results of investigation: the carefusion failure analysis lab received the print msb48907 and performed a failure investigation. The device worked as expected to service specifications and the failure could not be duplicated. The carefusion failure analysis lab received a second print msb48907 and an investigation was completed. The device worked as expected to service specifications and the failure could not be duplicated.
Patient Sequence No: 1, Text Type: N, H10
[54165994]
Results of investigation: the carefusion failure analysis lab received the masterscreen baby body box and performed a failure investigation. The root cause of the issue was found to be incorrect assembly of the device. The wiring of v1 and v2 was wrong, there was a bad soldering point on v2 and the squeeze sensors had no electrical alignment.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021710-2015-01932 |
| MDR Report Key | 5163546 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2015-10-21 |
| Date of Report | 2015-09-21 |
| Date of Event | 2015-08-06 |
| Date Mfgr Received | 2016-08-02 |
| Date Added to Maude | 2015-10-21 |
| 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 | RESPIRATORY THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JILL RITTORNO |
| Manufacturer Street | 75 NORTH FAIRWAY DR. |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 2627587805 |
| Manufacturer G1 | CAREFUSION |
| Manufacturer Street | LEIBNIZSTRASSE 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 | PLETHYSMOGRAPH, PRESSURE |
| Generic Name | MASTERSCREEN PAED-BABY BODY |
| Product Code | CCM |
| Date Received | 2015-10-21 |
| Returned To Mfg | 2015-10-06 |
| Model Number | MS-BABY BODY TP |
| Catalog Number | 001-175550 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | LEIBNIZSTRASSE 7 HOECHBERG 97204 GM 97204 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-10-21 |