MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA PERSEUS A500; ANESTHESIA UNITS

Catalog Number MK06000

Device Problems Gas Output Problem (1266); Decrease in Pressure (1490); Inaccurate Delivery (2339); Gas/Air Leak (2946); Misassembled During Installation (4049)

Patient Problem Apnea (1720)

Event Date 04/29/2021

Event Type  Injury  

Manufacturer Narrative

The investigation is still on-going.The results will be provided with a follow-up report.

Event Description

It was reported that after preparation, the patient was transferred into the room and ventilated on perseus in man/spon mode.Thereafter, the mode was changed to pressure-controlled mode.The operator had then noticed an "apnea" message and a low vt of 50.Because this was a vulnerable patient, surgery was stopped for safety reasons.No patient injury was reported.

Manufacturer Narrative

Based on the log analysis, the reported symptoms could be reconstructed.After the change of therapy from man/spont to vc-af, there was a drop in the applied tidal volume.The device behaved as specified and generated the corresponding alarms "mv low", "apnea" and "fresh gas low" to inform the user about the situation.It was further noted, according to the log records, that prior to the event in question, the hose system had been changed, but not re-tested for leakage.It was reported that the user had noticed a loose inspiration nozzle during the procedure.Using the selected user settings and a simulated leakage at the inspiratory nozzle, therapy was replicated.It could be shown that the device behaved identically to the available log records with regard to the low tidal volume and the generated alarms.Therefore, it can be concluded that a loose inspiration nozzle was the cause of the reported symptoms.However, as no new leakage test was carried out after changing the tube system, contrary to the instructions in the ga, the leakage could not be detected before patient use.Therefore, an user error could finally be determined as the cause for the reported symptoms and the subsequent termination of the operation.A device failure could not be found.

Event Description

It was reported that after preparation, the patient was transferred into the room and ventilated on perseus in man/spon mode.Thereafter, the mode was changed to pressure-controlled mode.The operator had then noticed an "apnea" message and a low vt of 50.Because this was a vulnerable patient, surgery was stopped for safety reasons.No patient injury was reported.

• Brand Name: PERSEUS A500
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 11847214
• MDR Text Key: 251357497
• Report Number: 9611500-2021-00212
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K133886
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MK06000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/14/2021
• Initial Date FDA Received: 05/19/2021
• Supplement Dates Manufacturer Received: 06/21/2021
• Supplement Dates FDA Received: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention