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

Model Number MODEL 100

Device Problem No Apparent Adverse Event (3189)

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

Event Date 07/19/2015

Event Type  malfunction  

Manufacturer Narrative

Zoll has not yet received the autopulse platform in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Event Description

It was reported that the autopulse platform displayed a "system error, out of service, revert to manual cpr" message.No adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform was returned to the manufacturer for evaluation on 08/19/2015.Investigation results are as follows: visual inspection was performed which found that the screw post on the encoder cover and motor cover was damaged.The battery partition cover was also observed to be missing.The physical damages noted during visual inspection are unrelated to the reported complaint of the autopulse platform displaying a "system error, out of service, revert to manual cpr" message.Please note that the autopulse lifeband was also returned for evaluation, however no damages were found during visual inspection.Functional testing was unable to be performed as the platform displayed a "system error" message upon power up of the device.Further inspection identified that the cause of the system error was due to a defective processor pca board.Following replacement of the pca board, the platform performed as intended with no other user advisories or warnings exhibited.A review of the archive data was attempted however the archive data files were unable to be saved as a result of the processor board being defective.Therefore, no data could be retrieved.Based on the investigation, the part identified for replacement was the defective processor board, encoder cover, motor cover, battery partition cover.In summary, the customer's reported complaint that the autopulse displayed a "system error" message was confirmed through functional testing.Further inspection identified that the processor board was defective.The physical damages found during visual inspection are unrelated to the customer's reported complaint.The autopulse is a reusable device and therefore, these types of physical damage can occur due to normal wear and tear and/or physical abuse.After replacement of the parts 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: 4993980
• MDR Text Key: 22642132
• Report Number: 3010617000-2015-00454
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 07/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2015
• 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: 08/19/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2005
• 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