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

Model Number MODEL 100

Device Problems Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 09/24/2015

Event Type  malfunction  

Manufacturer Narrative

Product in complaint will not be returned.Therefore, physical investigation cannot be performed.A supplemental report will be filed if the product in complaint is returned and investigation is completed.

Event Description

It was reported that the autopulse platform displayed a user advisory (ua) 08 (motor controller fault detected) message.The fan was also observed to be noisy when the device was powered on.No adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform ((b)(4)) was returned to zoll on (b)(6) 2015.Investigation results as follows: visual inspection: a visual inspection of the returned autopulse platform was performed and found no physical damage was noted.Archive review: a review of the platform archive was performed and user advisory (ua) 139 (unable to hold compression position) was observed to have occurred during the event date of (b)(6) 2015.Functional test: the device passed functional tests without any fault or error report.However, to find the cause of ua 139 observed during archive review, the brake gap inspection of the drive train motor was performed and found that the motor drive train brake gap was out of specification at (0.012").The brake gap could not be adjusted to the specification of (0.008").Both the set screws would not lock into the encoder dimple locking hole and caused the brake to disengage.Additionally, a run_in test with the 95% patient test fixture (lrtf) was performed and the device kept failing with user advisory 17 which was attributed to a faulty drive train motor.Based on the investigation, drive train motor was replaced to remedy the reported complaint.In summary, the customer's reported complaint of autopulse displaying ua 139 was confirmed during archive review and was attributed to a defective drive train motor.After the drive train motor was replaced, the platform passed all testing.Note that user advisory error messages are designed into the platform when one of several conditions is detected.The reported ua 18 and 2 are related to no load change detected at the load plate.These are potentially due to no patient present or patient too small.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM 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: 5164543
• MDR Text Key: 28807456
• Report Number: 3010617000-2015-00570
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2015
• 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