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

Model Number MODEL 100

Device Problem Failure to Power Up (1476)

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

Event Date 10/11/2015

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform (b)(4) was returned to the manufacturer for evaluation on 10/21/2015.Investigation results are as follows: visual inspection was performed which found that the front enclosure was cracked and the battery lock was bent.The physical damage observed during visual inspection is unrelated to the customer's reported complaint.A review of the autopulse platform's archive data was performed, which found that a user advisory 12 (lifeband not present) and a user advisory (ua) 18 (max take-up revolutions exceeded) message occurred on the reported event date of (b)(6) 2015, however these user advisories are unrelated to the customer's reported complaint.User advisory (ua) 12 occurs when the lifeband belt clip is not being detected in the platform spool shaft; which is likely due to incorrect or incomplete installation of the lifeband.User advisory (ua) 18 occurs when the driveshaft has moved past the maximum allowable takeup depth without detecting a patient, which is an indication that either the patient is too small or not present or the lifeband is opened.Functional evaluation of the returned autopulse platform was performed and the customer's reported complaint was unable to be duplicated.The platform was powered on/off with multiple nimh and li-ion batteries without any issues.The platform was also run with a test mannequin for 15 minutes and with a large resuscitation test fixture for 20 minutes and no faults were found.Based on the investigation the parts identified for replacement were the front enclosure and battery lock.In summary, the customer's reported complaint of the autopulse platform being unable to power up was not confirmed.The platform was powered on/off with multiple nimh and li-ion batteries and no issues occurred.No device deficiencies associated with the reported complaint were observed.The physical damages found during visual inspection are unrelated to the reported complaint.The platform is a reusable device and therefore, these types of damages can occur due to normal wear and tear and/or physical abuse.After replacement of the parts identified during investigation, the platform passed all final functional testing criteria.

Event Description

It was reported that during patient use, the autopulse platform powered up, however when the start/continue button was pressed, the lcd display turned off and the platform powered down.The battery was exchanged, however the issue would not resolve.The customer reverted to manual cpr (exact length of time was not provided), until a second autopulse platform was brought to the site.The outcome of the patient is unknown, however no adverse patient sequelae was reported.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM 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: 5208763
• MDR Text Key: 30688466
• Report Number: 3010617000-2015-00609
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000772
• UDI-Public: 00849111000772
• 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
• Type of Report: Initial
• Report Date: 10/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2015
• 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: 8700-0730-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2015
• 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
• Patient Age: 55 YR