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

Model Number MODEL 100

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 10/16/2014

Event Type  malfunction  

Event Description

It was reported that upon a shift check, the autopulse platform did not perform any compressions.Customer also reported that one of the head restraints was damaged.No patient involvement was reported.No further information was provided.

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.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 11/24/2014 for investigation.Investigation results as follows: visual inspection was performed and the reported issue of the head restraint wires being damaged was confirmed.Both top cover wire strands were broken.In addition, the load plate cover was damaged and the battery clip was missing.The platform performed as intended during functional testing.The reported issue of the platform not performing compressions could not be duplicated.A review of the platform's archive did not show any user advisories on the reported event date of (b)(6) 2014.Based on the investigation, the part(s) identified for replacement were the top cover, load plate cover and battery clip.In summary, the reported complaint that the platform did not perform compressions could not be duplicated.The platform performed as intended during functional evaluation.The reported complaint of the platform's head restraint wires being damaged was confirmed during visual inspection.

• 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: 4246571
• MDR Text Key: 18036308
• Report Number: 3010617000-2014-00603
• Device Sequence Number: 1
• Product Code: DRM
• 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: 10/23/2014

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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2014
• Initial Date FDA Received: 11/12/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2007
• 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