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

Model Number MODEL 100

Device Problems Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 12/04/2015

Event Type  malfunction  

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.

Event Description

It was reported that during a daily device check the autopulse platform s/n (b)(4) displayed a system error when powered on.No patient was involved when this occurred.During a preliminary check of the device by zoll (b)(4), they discovered that the device displayed a user advisory error 139 (unable to hold compression position).Zoll (b)(4) found that the clutch plate needed grinding.Once this was done, the system returned to full functionality.A full investigation/service will be conducted on this device upon which a supplemental mdr will be submitted.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to zoll (b)(4) for evaluation investigation results as follows: a visual inspection of the returned autopulse platform was performed and found no physical damage was noted.Archive review: a review of the platform archive was performed and user advisory (ua) 139 (unable to hold compression position) was observed.There was no other archive data stored that was before system error 139 occurring.During functional testing, the autopulse platform displayed ua 139 upon power up.The system error 139 was unlocked and the internal battery was replaced.Further investigation noted that the drive shaft would not rotate.The clutch plate was deburred to remedy the drive shaft not rotating.Note that the drive shaft not rotating is not related to the reported complaint of the platform displaying system error.In summary, the customer's reported complaint of autopulse displaying ua 139 was confirmed during archive review and functional testing and was attributed to a defective internal battery.After the battery was replaced the platform passed all functional testing.

• 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: 5332526
• MDR Text Key: 34596143
• Report Number: 3010617000-2015-00697
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111065009
• UDI-Public: 00849111065009
• 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: 04/14/2016

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2015
• Initial Date FDA Received: 12/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2007
• 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