MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number M3535A

Device Problems Disconnection (1171); Device Displays Incorrect Message (2591); No Pacing (3268)

Patient Problems Bradycardia (1751); Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)

Event Date 10/30/2016

Event Type  malfunction  

Event Description

Patient admitted via er to icu for gi bleed.Patient with history of end stage renal disease (esrd) on dialysis, pulmonary hypertension, atrial fib/flutter and possible amyloidosis.In er, there was a lengthy code blue and the patient received multiple units of prbc/ffp.Thereafter, the patient went to interventional radiology where no bleeding was found and then was transferred to icu.About an hour after he was admitted to icu, the patient developed pea and was coded again.During the code, we reestablished a pulse, but he was bradycardic with his heart rate in the 40's to 50's.It was decided to trial him with external pacing using the defibrillator with the hands free defibrillator pads (already attached) to see if it would help his blood pressure.Ekg leads were attached from the patient's chest to the defibrillator and pacing was started.After 4-5 successful beats of pacing, the defibrillator stopped pacing and said it could no longer pace because ekg leads were disconnected (it was the belief we still had a clear rhythm on the defibrillator screen, possibly through the pads).Ekg electrodes on chest were changed with the same result.A new lot of ekg electrodes were placed on the chest again with the same result.The ekg cable was changed with the same result.The defibrillator was changed and we had no further problems.

• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 6085114
• MDR Text Key: 59363555
• Report Number: 6085114
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: M3535A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/31/2016
• Device Age: 11 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CARDIAC DRUGS; VENT/AMBU BAG TO ETT, SCDS, IV PUMPS WITH 10 CHANN
• Patient Age: 76 YR
• Patient Weight: 79