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

Model Number MODEL 100

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 06/22/2017

Event Type  malfunction  

Manufacturer Narrative

Zoll has not yet received the zoll autopulse platform for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Event Description

As reported the autopulse platform (s/n: (b)(4)) did not function as intended during a shift check.Specifics as to what was observed on the platform was not provided.There is no report of patient involvement.

Manufacturer Narrative

The autopulse platform (s/n:(b)(4)) was returned to zoll for evaluation.The reported malfunction was confirmed.The drive train motor was replaced to remedy the issue.Visual inspection was performed and the short black cover was found damaged unrelated to the reported issue.During initial functional testing and archive data review, a user advisory (ua) 2 (compression tracking error) and a ua 16 (timeout moving to take-up position) message were observed.To resolve the ua messages, the drive train motor was replaced.Additionally, to ensure the platform is functional without further issue the damaged short black cover observed during visual inspection was also replaced.After the repair, the platform was re-evaluated.The platform passed testing with no faults found.An annual preventative maintenance was performed.The autopulse passed all final testing criteria.Historical complaints were reviewed for service information related to the reported complaint and there was no previous complaint reported for autopulse with serial number (b)(4).

• 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: 6719438
• MDR Text Key: 80220438
• Report Number: 3010617000-2017-00487
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000130
• UDI-Public: 00849111000130
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/22/2017

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: 8700-0700-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/22/2017
• Initial Date FDA Received: 07/17/2017
• Supplement Dates Manufacturer Received: 08/16/2017
• Supplement Dates FDA Received: 08/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2014
• 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