MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-02-04 for SEDASYS CONTROL UNIT SEDPRU01 manufactured by Ethicon Endo Surgery, Inc (cincinnati).
[37463045]
(b)(4). Additional information was requested and the following was obtained: the nurse did not remove the oral nasal cannula while she was performing bag mask ventilation. What does? Pru/control unit registered an o2 failure? Mean? When the patient recovered from the coughing event and their 02 saturations came back up, the nurse switched the oxygen control lever back and that was when the device registered an 02 failure and no oxygen was being delivered to the patient through the oral/nasal cannula. The patient reported having a cold so the assumption from the clinical staff in the room was the coughing episode was due to increase secretions. Did the pulse oximeter not register a value? Yes, the value displayed was 88% during the coughing episode. Was the oxygen not flowing? Not to the oral/nasal cannula after the nurse diverted oxygen with the oxygen control lever. Were the patient? S vital signs stable when the event began before the coughing? Yes. How much drug had been infused when the coughing started? I do not remember but it was early in the procedure. Was this an upper or lower gi procedure? The procedure was a colonoscopy and the patient reported having a cold in pre-procedure. If this was an upper gi, had the patient been given viscous lidocaine to anesthetize the throat before the procedure began? Na had the procedure started when this event happened? Yes they had already started the colonoscopy. What was the patient? S oxygen saturation before the coughing occurred? I am not sure of the exact value because i wasn? T in the room when it happened. The sedasys system log was reviewed by the medical safety officer in an attempt to confirm the reported event and to provide a clinical assessment. The following information was obtained: 1. The patient? S saturation was 96% to 99% during the first 20 minutes of the procedure. 2. Prior to the desaturation event, the patient? S respiration rate increased and became somewhat erratic (consistent with a patient coughing). 3. Over the next ~2 minutes the oxygen saturation decreased, reaching a minimum of 81% (not 88% as reported in the complaint). During those ~ 2 minutes: a. The saturation first decreased to 84% for a few seconds b. It rebounded to 87% for ~40 seconds c. Finally, it decreased to 81% for ~17 seconds 4. After analyzing the log data: a. The bag-mask ventilation started approximately 1 minute after the initial desaturation. I. The oxygen control lever on the back of the control unit was switched ~15 seconds after the patient's saturation decreased below 85% (the system's default red alarm threshold). Ii. The patient would have been receiving 12 l/min of oxygen because the saturation the saturation was less than 86% for ~17 seconds (the oxygen is split 50/50 between the nose and the mouth) b. The patient was bag masked for approximately 1 minute. I. The patient? S saturation increased above 85% ~50 seconds after the oxygen control lever was switched. Ii. The bagging most likely occurred at the start of these 50 seconds iii. The oxygen saturation continued to increase, reaching 92% after an additional ~10 seconds. 5. The device was rebooted and they continued on with the procedure without incident. 6. There was no patient consequence. In conclusion, the sedasys system performed as designed, there was no malfunction. The? O2 failure? Reported by the user, was the system alerting the clinical team that it could no longer provide the required oxygen flow rates because the inlet oxygen was diverted by the clinical team to the bag-mask.
Patient Sequence No: 1, Text Type: N, H10
[37463046]
It was reported that during a colonoscopy, a pru/control unit registered an oxygen (o2) failure. During the procedure the patient developed a minor coughing episode and desaturated to 88%. The nurse then used the bag mask that is attached to the back of the device and flipped the switch to divert oxygen delivery to the mask. She bag masked ventilated the patient for approximately 30 to 40 seconds and then the device registered as an o2 failure and drug delivery was stopped. The device was rebooted and they continued on with the procedure without incident. There was no patient consequence. No device will be returned.
Patient Sequence No: 1, Text Type: D, B5
[37493650]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1527736-2016-00004 |
| MDR Report Key | 5410185 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-02-04 |
| Date of Report | 2016-01-07 |
| Date of Event | 2016-01-07 |
| Date Mfgr Received | 2016-01-28 |
| Date Added to Maude | 2016-02-04 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MILTON GARRETT |
| Manufacturer Street | 4545 CREEK ROAD ML 120A |
| Manufacturer City | CINCINNATI OH 45242 |
| Manufacturer Country | US |
| Manufacturer Postal | 45242 |
| Manufacturer Phone | 5133378865 |
| Manufacturer G1 | MACK MOLDING COMPANY |
| Manufacturer Street | 608 WARM BROOK RD |
| Manufacturer City | ARLINGTON VT 05250 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 05250 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SEDASYS CONTROL UNIT |
| Generic Name | COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM |
| Product Code | PDR |
| Date Received | 2016-02-04 |
| Model Number | NA |
| Catalog Number | SEDPRU01 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON ENDO SURGERY, INC (CINCINNATI) |
| Manufacturer Address | 4545 CREEK RD CINCINNATI OH 452422803 US 452422803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-02-04 |