MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 09/15/2016

Event Type  malfunction  

Manufacturer Narrative

The autopulse, serial number (sn) (b)(4), was returned for evaluation and repair on 9/22/2016.A visual inspection indicated a 'sticky' encoder shaft, and the top cover metalized coating layer was corroded with fluid.These issues are unrelated to the reported complaint.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of related complaints for autopulse sn (b)(4).A review of the autopulse archive indicated an occurrence of ua7 (discrepancy between load 1 and load 2 too large) confirming the customer's complaint.The initial functional test passed without any faults, ua's, or errors, indicating that the ua7 observed in the archive was cleared by the user.Additional testing showed that the load sensing system had detected a weight/load imbalance between the two load cells, which is checked during power-on self-test.Load cell characterization test indicates load cell module 2 was under reported (defective).In summary the customers reported complaint of the autopulse displaying ua7 was confirmed during the archive review but not functional testing.Additional testing showed that the load cell module 2 was defective, but still functioning.

Event Description

The customer reported that the autopulse (ap) was displaying user advisory (ua) 7 (discrepancy between load 1 and load 2 too large), after the patient was placed on the platform.This may be due to the patient being large and the platform being placed on a slope.The patient was removed from the autopulse and manual cpr was performed.No other patient information is available.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 6018824
• MDR Text Key: 57084399
• Report Number: 3010617000-2016-00718
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00084911100027
• UDI-Public: 0084911100027
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Paramedic
• Type of Report: Initial
• Report Date: 10/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Paramedic
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0700-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1