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

Model Number MODEL 100

Device Problem Device Inoperable (1663)

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

Event Date 11/21/2014

Event Type  malfunction  

Event Description

Complainant alleged that the autopulse® platform motor is not working and the lifeband will not perform take up.It is unknown when this issue was identified, however no adverse patient sequelae was reported.No further details were provided.

Manufacturer Narrative

Zoll has not received the product in complaint.A supplemental report will be filed if and when the product is returned and investigation has been performed.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to zoll (b)(4) for analysis.External visual inspection of the returned platform shows that the short black cover was split.Internal visual inspection of the returned platform shows no damage.The external damage found during visual inspection is not related to the reported complaint.The damage appears to have been caused by normal wear and tear (autopulse manufactured in 12/2007).A review of the autopulse archive was performed and the archive data shows that a ua45 (not at "home" position after power-on/restart) fault occurred on the reported event date of (b)(6) 2014.Functional testing was performed and the ua45 fault was displayed when the platform was powered on.The ua45 fault was cleared.Upon clearing the fault, the platform passed the functional test.Based on the investigation, the parts identified for replacement were the short black cover and the white nylon screws.In summary, the reported complaint was confirmed based on review of the archive and during functional testing.The fault was found to be due to the lifeband straps not being completely pulled out prior to turning the platform on, resulting in the driveshaft not being at the home position.Per the autopulse® resuscitation system model 100 user guide (pn: 12555-001), if the driveshaft is not at its home position when the autopulse is powered on, a user advisory (45) will occur.This user advisory will persist until the driveshaft is returned to its home position.To clear a user advisory (45) pull up on the lifeband until the chest bands are fully extended (thereby moving the driveshaft back to its home position), and then restart.The physical damage found during visual inspection is unrelated to the reported complaint.Upon replacement of all parts, the platform was re-evaluated through functional testing and the platform passed all testing criteria.

• 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: 4323701
• MDR Text Key: 5213665
• Report Number: 3010617000-2014-00658
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Type of Report: Initial,Followup
• Report Date: 11/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 12/18/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2015
• Initial Date FDA Received: 12/11/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/30/2007
• 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