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

Model Number MODEL 100

Device Problems Visual Prompts will not Clear (2281); Issue With Displayed Error Message (2967)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/27/2015

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 08/10/2015 for investigation.Investigation results as follows: visual inspection of the returned platform was performed and found no visible or physical damages to the platform.A review of the platform's archive data was performed and found one occurrence of system error code 132 (internal watchdog timeout) on (b)(6) 2015, rather than on the reported event date of (b)(6) /2015, thus confirming the customer's reported complaint.The reported "system error" message was duplicated when the returned platform was powered on for functional testing.Further investigation determined that the processor board was defective.Based on the investigation, the part identified for replacement was the processor board.In summary, the customer's reported complaint of the platform displaying a "system error" message was confirmed through review of the platform's archive data and was also replicated upon functional testing of the returned platform.The root cause was determined to be a defective processor board.After replacement of the processor board, the platform successfully passed all final functional testing.

Event Description

It was reported that during a code, the autopulse platform performed compressions for a short while (exact length of time was not provided) and then displayed a "system error" message that would not clear.Customer switched to another autopulse platform to treat the patient.No adverse patient sequelae was reported.No further information was provided.

• 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: 5012551
• MDR Text Key: 23386207
• Report Number: 3010617000-2015-00464
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• 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
• Source Type: health professional
• Reporter Occupation: Health Professional
• Report Date: 07/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2015
• 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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2015
• 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