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 error code 03 (error communicating with battery controller) and error code 18 (max take-up revolutions exceeded) messages.No adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 07/31/2015 for investigation.Investigation results are as follows: visual inspection of the returned platform was performed and did not reveal any visible or physical damages to the platform.The customer's reported complaint of the platform displaying error code 03 (error communicating with battery controller) and error 18 (max take-up revolutions exceeded) messages could not be confirmed because the platform's archive data was not reviewed.The reported error codes 03 and 18 were not replicated during functional testing of the returned platform.The platform successfully passed all initial and final functional testing without any issues.Based on the investigation, no parts were identified for replacement.In summary, the customer's reported complaint of the platform displaying error codes 03 and 18 messages was not confirmed.The platform successfully passed all initial and final functional testing without any issues.Per the autopulse maintenance guide, user advisory (ua) 3 is an indication that the battery may be loose or not fully inserted and ua 18 is an indication that the autopulse has detected that either the patient's chest is too small while sizing the patient (take-up) or that there is no patient on the platform.The immediate actions to take when a ua 3 occurs are to remove the battery and check the connector on the battery for damage.If the connector on the battery is not damaged, the battery can be reinstalled into the platform to begin/resume compressions.However, if the connector is damaged, the battery should be taken out of service.Users should then open the lifeband and start manual cpr.The recommended actions to take when a ua 18 occurs are to: pull up completely on the lifeband, ensure that the patient and the band are properly aligned, and press restart.If the user advisory does not clear, the patient may be too small.In this case, revert to manual cpr.It should be noted that the customer did not return any batteries for evaluation.In addition, customer did not provide any information regarding the patient's size.There were no device deficiencies found during evaluation of the platform which could have caused or contributed to the reported error codes 03 and 18 messages.Therefore, a root cause for the reported complaint could not be determined.

• 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: 4993983
• MDR Text Key: 22640578
• Report Number: 3010617000-2015-00458
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001052
• UDI-Public: 00849111001052
• 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: 8700-0740-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2011
• 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