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

Model Number MODEL 100

Device Problems Bent (1059); Device Operates Differently Than Expected (2913)

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

Event Date 01/20/2016

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 01/27/2016 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Event Description

The customer reported that during shift check, they encountered difficulty locking the li-ion battery inside the autopulse platform, thus cause the platform not to power up.Inspection of the autopulse battery compartment revealed the battery connector was bent.No patient involvement was reported.No additional information was provided.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to zoll for evaluation on 01/27/2016.Visual inspection was performed and no damage was observed to the enclosure.A review of the archive was performed and numerous user advisory (ua) 07 were noticed for (b)(6) 2015, no other significant problems were found.The battery connector was noted to be damaged therefore it was unable to insert the battery in place and thus the autopulse platform did not power on.In summary, the reported complaint of the battery connector broken was confirmed.The autopulse platform is a reusable device and was manufactured on 05/21/07.Therefore, this type of physical damages is characteristic of normal wear and tear for the life of the device.The battery cable was replaced to resolve the issue.A root cause for the observed ua code cannot be determined.The autopulse platform passed load cell characterization test and both load cells were within specification.A run_in testing was performed using the 95% patient test fixture (lrtf) for 18 minutes, and device did not duplicate any of the user advisory or fault.In summary, the autopulse has passed all the testing and meets all required specifications.

• 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: 5435686
• MDR Text Key: 38228340
• Report Number: 3010617000-2016-00088
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• 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,Followup
• Report Date: 04/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2016
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2007
• 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