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

Model Number MODEL 100

Device Problems No Display/Image (1183); Failure to Power Up (1476)

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

Event Date 06/22/2015

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll (b)(4) for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Event Description

It was reported that during a device check, the backlight of the autopulse platform's lcd display did not turn on properly.No patient involvement was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform was returned to zoll (b)(4) for evaluation.Investigation results are as follows: visual inspection of the returned autopulse platform was performed and it was found that the lcd was defective, thus confirming the customer's reported complaint.A review of the autopulse platform's archive data was performed and multiple user advisories (uas) such as 18 (max take-up revolutions exceeded) and 45 (not at "home" position after power-on/restart) messages were observed on the reported event date.In addition, other user advisories (uas) such as 02 (compression tracking error), ua 07 (discrepancy between load 1 and load 2 too large), 12 (lifeband not present) and 17 (max motor on time exceeded during active operation) were observed on other dates.Please note that these user advisory messages are unrelated to the customer's reported complaint.Functional evaluation of the platform was performed and the customer's reported complaint was unable to be duplicated.Unrelated to the reported complaint, it was observed that the driveshaft was difficult to rotate.The clutch plate was deburred to address this issue.Based on the investigation, the part identified for replacement was the lcd transmissive cable.In summary the customer's reported complaint that the backlight of the autopulse platform's lcd display being unable to turn on properly was confirmed during visual inspection, however the issue was unable to be duplicated during functional testing.The root cause was determined to be that the lcd transmissive cable was defective.After replacement of the part identified during investigation, the platform successfully passed all final functional testing.

• 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: 4940378
• MDR Text Key: 22866813
• Report Number: 3010617000-2015-00416
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 07/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2015
• 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: 8700-0700-03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2011
• 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