MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-02-21 for 1859 1859RR manufactured by Stryker Sustainability Solutions Lakeland.
[100646047]
The complaint device was not returned to stryker sustainability solutions for evaluation. The device was not saved. As the complaint device was not returned, a conclusive root cause could not be determined and the reported event could not be confirmed. A review of the dhr could not be performed as the lot number was not reported. A review of internal procedures supports that the device was unlikely to have been released from stryker with the reported failure mode. The reported event may be attributed to: sensor not applied properly. Device is used in conditions where inaccurate readings are obtained. Patient motion. Ambient light. Failure of sensor or sensor circuit. Failure of led or led circuit. The reported event will continue to be monitored through post-market surveillance. Should the device become available for return, the investigation will be reopened.
Patient Sequence No: 1, Text Type: N, H10
[100646048]
It was reported that the pulse oximeter sensor gave inaccurate readings. The facility reported that on a relatively sick patient, a procedure was aborted to resuscitate the patient from hypoxia with a tremendous a-a gradient, including the use of advanced testing like bedside echo, intracardiac echo and the facility was considering echmo. It was determined the patient wasn't really hypoxic. After getting abg results that conflicted with the data seen in the lab, the facility switched the probe, and the patient? S saturation went from 68% to 100% immediately. The patient ended up going intubated to the icu after an aborted procedure. Multiple attempts were made to obtain clarity and additional information from the facility. No information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001056128-2018-00010 |
| MDR Report Key | 7287829 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-02-21 |
| Date of Report | 2018-02-21 |
| Date of Event | 2018-01-22 |
| Date Mfgr Received | 2018-01-23 |
| Date Added to Maude | 2018-02-21 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MARISSA RICHMOND |
| Manufacturer Street | 1810 W. DRAKE DRIVE |
| Manufacturer City | TEMPE AZ 85283 |
| Manufacturer Country | US |
| Manufacturer Postal | 85283 |
| Manufacturer Phone | 8888883433 |
| Manufacturer G1 | STRYKER SUSTAINABILITY SOLUTIONS LAKELAND |
| Manufacturer Street | 5307 GREAT OAK DRIVE |
| Manufacturer City | LAKELAND FL 33815 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33815 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NA |
| Generic Name | OXIMETER, REPROCESSED |
| Product Code | NLF |
| Date Received | 2018-02-21 |
| Model Number | 1859 |
| Catalog Number | 1859RR |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER SUSTAINABILITY SOLUTIONS LAKELAND |
| Manufacturer Address | 5307 GREAT OAK DRIVE LAKELAND FL 33815 US 33815 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-21 |