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

Model Number MODEL 100

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 11/09/2015

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll (b)(4) on 11/13/2015 for a preventative maintenance and investigation results as follows: visual inspection: no physical damage impact noted upon receipt.Review of archive data log: a review of the platforms archive data log was performed and found user advisories (ua) 16 (timeout moving to take-up position) and 42 (force overload tripped), which confirmed the reported complaint of receiving "error codes." based on the investigation results, no parts were identified for replacement.No information available if the user advisories were replicated during functional testing.Conclusion: in summary, the reported issue of the customer receiving error codes was confirmed during a review of the archive data log.There were no parts identified that needed replacing.The customer's issue was resolved once they reconnected the "disconnected" cable.The platform passed all functional testing during the preventative maintenance and was returned to the customer in fully functional.

Event Description

The customer reported that their autopulse platform s/n (b)(4) was displaying error codes.At the time of the report, the customer did not know the error codes.The customer reported seeing a disconnected cable.Which they reconnected.No patient involvement was disclosed.No further information was provided.

• 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: 5278105
• MDR Text Key: 33040681
• Report Number: 3010617000-2015-00657
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001052
• UDI-Public: 00849111001052
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 11/16/2015

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: 8700-0740-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2015
• Initial Date FDA Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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