Returned device was received in poor physical condition but the top case was chipped and cracked. Evidence of reported problem in event log was found. During the evaluation of the device, it was found that the c9 cap was loose on the interconnect board. This was noted to be customer induced damage due to the case damage. The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution. No issues were identified that would have impacted this event.
Patient Sequence No: 1, Text Type: N, H10
Information was received indicating that a smiths medical medfusion syringe pump had a force sensor error. The patient was no impacted by the event. No adverse events were reported.
Patient Sequence No: 1, Text Type: D, B5