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

Model Number MODEL 100

Device Problems Device Stops Intermittently (1599); Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/05/2016

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on (b)(4) 2016 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Event Description

It was reported that during patient use the autopulse platform (s/n (b)(4)) stopped functioning after 3-4 compressions.The customer repeated the restart process a few times until the device displayed a system error at which time the use of the autopulse was suspended.The crew had to revert to manual cpr.No patient information was disclosed.No further information was provided.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to zoll (b)(4) on 01/20/2016 for evaluation.Device history record (dhr) was reviewed and no previous related complaint was reported for this autopulse platform (s/n (b)(4)).A visual inspection of the returned platform was performed and no visible damages were observed.A review of the autopulse's archive was performed and it showed latch error139 (unable to hold compression position) occurring on the reported event date of (b)(6) 2015, thus confirming the reported complaint.The platform was functionally tested and found the drive train brake gap was out of specification was at fault.Further investigation indicated that the brake gap was not able to adjust to its specification and the encoder dimple locking hole would not lock and caused the brake to disengage.In summary, the customer's reported complaint was confirmed during archive review and functional testing.The root cause was determined to be a defective drive train and clutch plate.After the drive train and clutch plate were replaced, the platform passed testing and met 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: 5411791
• MDR Text Key: 37520697
• Report Number: 3010617000-2016-00057
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111065108
• UDI-Public: 00849111065108
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/30/2016

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: 8700-0700-03-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2016
• Initial Date FDA Received: 02/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2014
• 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