MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS; OXIMETER, REPROCESSED

Model Number DWG5120-05

Device Problems Failure to Read Input Signal (1581); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2014

Event Type  malfunction  

• Type of Device: OXIMETER, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS; 5300 regions court; lakeland FL 33815
• MDR Report Key: 4701270
• Report Number: 4701270
• Device Sequence Number: 1
• Product Code: DQA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Invalid Data
• Type of Report: Initial
• Report Date: 04/10/2015
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: DWG5120-05
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 1 DAY
• Patient Weight: 3