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 07/22/2015

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 an intermittent "check patient alignment" 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 08/03/2015.Investigation results are as follows: visual inspection was performed and no visible damages were observed to the platform.Functional evaluation of the returned platform was performed and the customer's reported complaint of the autopulse platform displaying a "check patient alignment" message was not observed.The autopulse platform was run with a (b)(6) large resuscitation test fixture (lrtf) for 45 minutes and no user advisories or warnings were observed.Based on the investigation, no parts were replaced to remedy the customer's reported complaint.In summary the customer's reported complaint of the autopulse platform displaying a "check patient alignment" message was not confirmed.In addition, the reported complaint was not duplicated during functional testing.There were no device deficiencies found during evaluation of the platform which could have caused or contributed to the reported complaint.Therefore, a root cause could not be determined.The platform passed all final testing criteria.

• 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: 4993982
• MDR Text Key: 22638675
• Report Number: 3010617000-2015-00457
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000116
• UDI-Public: 00849111000116
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 07/22/2015

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: 8700-0700-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2008
• 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